AzTrials
AzTrials

Anatomic Stage I Breast Cancer AJCC v8Phase 3NCT05929768

Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

A Phase 3 study testing Biospecimen Collection, Carboplatin and Cyclophosphamide in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by SWOG Cancer Research Network at 963 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Carboplatin and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
963 sitesin 3 countries
Study dates
15 Sep 2023to Apr 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined as ER < 5%, PR < 5%, and HER2 negative (per 2020 American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines)
  • NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended/planned by the treating physician
  • Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor clinical stage either
  • T2-T4, N0, M0 or
  • T1-T3, N1-2, M0
  • Note: All participants with clinically suspicious nodes must undergo core needle biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status
Show all 52Show fewer
  • Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or magnetic resonance imaging (MRI) within 49 days prior to randomization
  • Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria
  • Participants must not have T4/N+, any N3, or inflammatory breast cancer
  • Participants must not have metastatic disease (M1)
  • Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer
  • Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer
  • Participants must not have current or anticipated use of other investigational agents while participating in this study
  • Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition as study agents
  • Participants must not have severe hypersensitivity (>= grade 3) to pembrolizumab or any of its excipients
  • Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)
  • Participants must not be currently participating in or have participated in a study of an investigational agent or used an investigational device within 28 days prior to randomization
  • Participants must be >= 18 years old
  • Participants must have Zubrod performance status of 0-2
  • Participants with evidence of peripheral neuropathy must have it at =< grade 1, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to randomization
  • Participants must have a complete medical history and physical exam within 28 days prior to randomization
  • Hemoglobin >= 9.0 g/dL or >= 5.6 mol/L (within 28 days prior to randomization)
  • (Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)
  • Leukocytes >= 3 x 10^3/uL (within 28 days prior to randomization)
  • Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to randomization)
  • Platelets >= 100 x 10^3/uL (within 28 days prior to randomization)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN), OR direct bilirubin =< IULN for participants with total bilirubin > 1.5 x IULN (unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional IULN) (within 28 days prior to randomization)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)
  • Participants must have a serum creatinine =< the IULN OR calculated creatinine clearance >= 50 mL/min/1.73m^2 using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
  • Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction >= 50% as assessed by either echocardiography (ECHO) or multigated acquisition scan (MUGA) assessed within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better
  • Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
  • Note: No testing for Hepatitis B is required unless mandated by local health authority
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
  • Note: No testing for hepatitis C is required unless mandated by local health authority
  • Participants with history of diabetes must not have uncontrolled diabetes in the opinion of the treating investigator
  • Participants must not have uncontrolled hypertension in the opinion of the treating investigator
  • Participants must not have had a major surgery within 14 days prior to randomization. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator
  • Participants must not have severe or active infections within 14 days prior to Randomization, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia
  • Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
  • Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
  • Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis
  • Participants must not have received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist [registered trademark]) are live attenuated vaccines and are not allowed
  • Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen
  • Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
  • Participants must have one (1) physical 4-5-micron single hematoxylin and eosin (H\&E) slide from the archival pretreatment diagnostic biopsy available for submission
  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
  • Participants who can complete questionnaires in English, Spanish, or French must be offered the opportunity to participate in the Patient-Reported Outcome study
  • NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
  • As part of the registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Who cannot join

None listed.

Trial locations and contacts

963 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Alicia Aranda contact

210-614-8808

aaranda@swog.org

Dana Sparks contact

210-614-8808

dsparks@swog.org

308 sites in 3 countries

United States300 sites, 287 recruiting

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-539-2273, info@hawaiicancercare.com

    Jodi A. Kagihara

    Recruiting

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-486-6000

    Jodi A. Kagihara

    Recruiting

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-487-7447

    Jodi A. Kagihara

    Recruiting

  • Straub Pearlridge Clinic

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-522-4333

    Jodi A. Kagihara

    Recruiting

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-678-9000

    Jodi A. Kagihara

    Recruiting

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

    Site Public Contact, rohta@queens.org

    Jodi A. Kagihara

    Recruiting

  • UM Upper Chesapeake Hematology and Oncology - Aberdeen

    Aberdeen, Maryland, 21001

    Site Public Contact, 443-643-1029, nfadrwoski@umm.edu

    Katherine H. Tkaczuk

    Recruiting

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Charles W. Drescher

    Recruiting

  • Hickman Cancer Center

    Adrian, Michigan, 49221

    Suspended

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

    Site Public Contact, 330-375-4221, cancerresearch@summahealth.org

    Bradley T. Clifford

    Recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • Aultman Alliance Community Hospital

    Alliance, Ohio, 44601

    Site Public Contact, 330-363-1250

    Sunitha Vemulapalli

    Recruiting

  • MyMichigan Medical Center Gratiot

    Alma, Michigan, 48801

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Christopher M. Reynolds

    Recruiting

  • MyMichigan Medical Center Alpena

    Alpena, Michigan, 49707

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Christopher M. Reynolds

    Recruiting

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Site Public Contact, 618-463-5623

    Jay W. Carlson

    Recruiting

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com

    Joseph J. Merchant

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Sujatha Murali

    Recruiting

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Charles W. Drescher

    Recruiting

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

    Suspended

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Charles W. Drescher

    Recruiting

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Charles W. Drescher

    Recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Charles W. Drescher

    Recruiting

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Suspended

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Charles W. Drescher

    Recruiting

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Charles W. Drescher

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, slusserb@med.umich.edu

    Erin F. Cobain

    Recruiting

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

    Active, not recruiting

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Site Public Contact, 920-364-3604, ResearchDept@thedacare.org

    Shannon Schmidt

    Recruiting

  • Ascension Saint Elizabeth Hospital

    Appleton, Wisconsin, 54915

    Site Public Contact, AWRI.inquiry@ascension.org

    Francis J. Cuevas

    Recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • PCR Oncology

    Arroyo Grande, California, 93420

    Site Public Contact, 702-384-0013, research@sncrf.org

    John A. Ellerton

    Recruiting

  • Cone Health Cancer Center at Asheboro

    Asheboro, North Carolina, 27203

    Suspended

  • Cone Health MedCenter Asheboro

    Asheboro, North Carolina, 27205

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

    Site Public Contact, 828-650-8037, AMBER.WHEELER@AdventHealth.com

    Jennifer L. Heaberlin

    Recruiting

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Jade Jones

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Jade Jones

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Jade Jones

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Jade Jones

    Recruiting

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

    Site Public Contact, clinicalresearch@sutterhealth.org

    Uma Suryadevara

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

    Site Public Contact, clinicalresearch@sutterhealth.org

    Uma Suryadevara

    Recruiting

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, Georgia, 30901

    Site Public Contact, 706-821-2944

    Sharad A. Ghamande

    Recruiting

  • Augusta Oncology Associates PC-Wheeler

    Augusta, Georgia, 30909

    Site Public Contact, 706-736-1830

    Sharad A. Ghamande

    Recruiting

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

    Site Public Contact, 207-626-4855

    Erin Adler

    Recruiting

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu

    Maria T. Grosse-Perdekamp

    Recruiting

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting

  • Dell Seton Medical Center at The University of Texas

    Austin, Texas, 78701

    Site Public Contact, 512-324-7991

    Ala'a Eddin Tayyem

    Recruiting

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Site Public Contact, 305-674-2625, yenrique@msmc.com

    Oleg Gligich

    Recruiting

  • Hartford HealthCare - Avon

    Avon, Connecticut, 06001

    Site Public Contact, 860-972-4700

    Wylie D. Hosmer

    Recruiting

  • IU Health West Hospital

    Avon, Indiana, 46123

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Kathy D. Miller

    Recruiting

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Christopher M. Reynolds

    Recruiting

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Sujatha Murali

    Recruiting

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Katherine H. Tkaczuk

    Recruiting

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

    Site Public Contact, 330-375-4221, cancerresearch@summahealth.org

    Bradley T. Clifford

    Recruiting

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Thomas J. Saphner

    Recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Essentia Health - Baxter Clinic

    Baxter, Minnesota, 56425

    Site Public Contact, 218-828-2880

    Bret E. Friday

    Recruiting

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

    Site Public Contact, 516-734-8896

    Brittney S. Zimmerman

    Recruiting

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

    Site Public Contact, 443-643-3010

    Katherine H. Tkaczuk

    Recruiting

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Meghana Kesireddy

    Recruiting

  • FHCC Overlake

    Bellevue, Washington, 98004

    Site Public Contact, 425-454-2148

    Goldy Bansal

    Recruiting

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Sujatha Murali

    Recruiting

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Site Public Contact, 360-788-8223

    Charles W. Drescher

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Saint Charles Health System

    Bend, Oregon, 97701

    Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org

    Charles W. Drescher

    Recruiting

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

    Site Public Contact, clinicalresearch@sutterhealth.org

    Uma Suryadevara

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Kara K. Landry

    Recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

    Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu

    Sneha D. Phadke

    Recruiting

  • Beverly Hospital

    Beverly, Massachusetts, 01915

    Site Public Contact, 978-922-3000 ext. 2405

    Andrew Piper-Vallillo

    Recruiting

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

    Site Public Contact, towercancerresearch@toweroncology.com

    Yuan Yuan

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

    Site Public Contact, 800-648-6274

    Karng S. Log

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Site Public Contact, 205-895-1816, charlesbaldwin@uabmc.edu

    Nusrat Jahan

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

    Site Public Contact, 912-819-5704, underberga@sjchs.org

    Alison E. Spellman

    Recruiting

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Joseph J. Stephenson

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Charles W. Drescher

    Recruiting

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Site Public Contact, 617-638-8265

    Jose J. Acevedo Mejia

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Site Public Contact, 617-667-9925

    Emily S. Gatof

    Recruiting

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • Hartford HealthCare - Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

    Site Public Contact, 860-972-4700

    Wylie D. Hosmer

    Recruiting

  • United Hospital Center

    Bridgeport, West Virginia, 26330

    Suspended

  • Intermountain Health Platte Valley Hospital

    Brighton, Colorado, 80601

    Site Public Contact, peaksresearch@imail.org

    Karng S. Log

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    Erin F. Cobain

    Recruiting

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Francis J. Cuevas

    Recruiting

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

    Site Public Contact, 646-754-4624, david.wallach@nyulangone.org

    Natalie J. Klar

    Recruiting

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

    Site Public Contact, 484-476-2649, turzoe@mlhs.org

    Arezoo Ghaneie

    Recruiting

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Site Public Contact, 818-847-4793, Najee.Boucher@providence.org

    Charles W. Drescher

    Recruiting

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

    Site Public Contact, clinicalresearch@sutterhealth.org

    Uma Suryadevara

    Recruiting

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

    Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org

    Andrew Piper-Vallillo

    Recruiting

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Kara K. Landry

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Kara K. Landry

    Recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527

    Site Public Contact, 708-216-9000

    Jennifer A. Weiss

    Recruiting

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

    Site Public Contact, 406-723-2621

    Karng S. Log

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

    Site Public Contact, clinicalresearch@sutterhealth.org

    Uma Suryadevara

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Sunitha Vemulapalli

    Recruiting

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Site Public Contact, 618-457-5200, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • IU Health North Hospital

    Carmel, Indiana, 46032

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Kathy D. Miller

    Recruiting

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

    Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org

    Shahzad Siddique

    Recruiting

  • Caro Cancer Center

    Caro, Michigan, 48723

    Suspended

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

    Site Public Contact, 702-384-0013, research@sncrf.org

    John A. Ellerton

    Recruiting

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Site Public Contact, 618-985-3333, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

    Site Public Contact, clinicalresearch@sutterhealth.org

    Uma Suryadevara

    Recruiting

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-365-4673

    Deborah W. Wilbur

    Recruiting

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-363-2690

    Deborah W. Wilbur

    Recruiting

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Jhansi L. Koduri

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

    Site Public Contact, protocols@swog.org

    Jay W. Carlson

    Recruiting

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Charles W. Drescher

    Recruiting

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Marianne Spengler

    Recruiting

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

    Site Public Contact, 717-217-6020

    Marianne Spengler

    Recruiting

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

    Site Public Contact, 316-291-4774, research@viachristi.org

    Dennis F. Moore

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Yara Abdou

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Trish Millard

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Ana Maria Lopez

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Lisa E. Flaum

    Recruiting

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

    Site Public Contact, 312-864-5204

    Deimante M. Tamkus

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Lydia Usha

    Recruiting

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

    Site Public Contact, 773-878-8200

    Poornima Saha

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Rita Nanda

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Thomas J. Saphner

    Recruiting

  • Ascension Calumet Hospital

    Chilton, Wisconsin, 53014

    Site Public Contact, AWRI.inquiry@ascension.org

    Francis J. Cuevas

    Recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Foluso O. Ademuyiwa

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Charles W. Drescher

    Recruiting

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Morton Plant Hospital

    Clearwater, Florida, 33756

    Site Public Contact, 855-314-8646

    Vijaya K. Gadiyaram

    Recruiting

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

    Site Public Contact, 828-650-8037, AMBER.WHEELER@AdventHealth.com

    Jennifer L. Heaberlin

    Recruiting

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

    Suspended

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Philip E. Lammers

    Recruiting

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Uchenna O. Njiaju

    Recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Site Public Contact, 719-364-6700

    Uchenna O. Njiaju

    Recruiting

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Philip E. Lammers

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Dionisia Quiroga

    Recruiting

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

    Site Public Contact, 603-224-2556

    Michael S. Buff

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org

    Charles W. Drescher

    Recruiting

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

    Site Public Contact, 859-523-1934

    Mounika Mandadi

    Recruiting

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

    Suspended

  • UPMC Hillman Cancer Center - Passavant - Cranberry

    Cranberry Township, Pennsylvania, 16066

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Adam M. Brufsky

    Recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org

    Richard L. Deming

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Foluso O. Ademuyiwa

    Recruiting

  • Essentia Health - Saint Joseph's Crosslake Clinic

    Crosslake, Minnesota, 56442

    Site Public Contact, 218-692-1010

    Bret E. Friday

    Recruiting

  • Northwest Cancer Center - Main Campus

    Crown Point, Indiana, 46307

    Site Public Contact, 219-310-2550

    Maria T. Grosse-Perdekamp

    Recruiting

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

    Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Rita Nanda

    Recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Thomas J. Saphner

    Recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

    Site Public Contact, 240-964-1400

    Adam M. Brufsky

    Recruiting

  • Danbury Hospital

    Danbury, Connecticut, 06810

    Site Public Contact, 203-739-8074

    Madhura Hanmantgad

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Maria T. Grosse-Perdekamp

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Jennifer R. Collins

    Recruiting

  • Sutter Davis Hospital

    Davis, California, 95616

    Site Public Contact, NCIclinicaltrials@sutterhealth.org

    Uma Suryadevara

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Jhansi L. Koduri

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Jhansi L. Koduri

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Jhansi L. Koduri

    Recruiting

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

    Site Public Contact, 248-551-7695

    Deepa B. Jagtap

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org

    Jade Jones

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Broward Health North

    Deerfield Beach, Florida, 33064

    Site Public Contact, 954-941-8300

    Shannon B. Keating

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Lisa E. Flaum

    Recruiting

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

    Site Public Contact, 303-777-2663

    Karng S. Log

    Recruiting

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

    Site Public Contact, 877-225-5654, glicht@co-cancerresearch.org

    Karng S. Log

    Recruiting

  • The Women's Imaging Center

    Denver, Colorado, 80209

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • AdventHealth Porter

    Denver, Colorado, 80210

    Site Public Contact, research.institute@adventhealth.com

    Nadine G. Mikhaeel-Kamel

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

    Site Public Contact, 303-318-3413

    Karng S. Log

    Recruiting

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Daniel S. O'Neil

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Lubina Arjyal

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Haythem Y. Ali

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

    Site Public Contact, 877-204-6081, hemoncctrials@geisinger.edu

    Jennifer R. Collins

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Site Public Contact, 815-285-7800

    Bryan A. Faller

    Recruiting

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

    Site Public Contact, 316-291-4774, research@viachristi.org

    Dennis F. Moore

    Recruiting

  • Bayhealth Hospital Kent Campus

    Dover, Delaware, 19901

    Site Public Contact, 302-674-4401, clinical_trials@bayhealth.org

    Iftekhar A. Khan

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Irene M. Kang

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • CommonSpirit Cancer Center Mercy

    Durango, Colorado, 81301

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Mercy Medical Center

    Durango, Colorado, 81301

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Maria T. Grosse-Perdekamp

    Recruiting

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Joseph J. Stephenson

    Recruiting

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Christopher M. Reynolds

    Recruiting

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

    Suspended

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Patcharin Tanawattanacharoen

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Charles W. Drescher

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Maria T. Grosse-Perdekamp

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

    Site Public Contact, 316-291-4774, research@viachristi.org

    Dennis F. Moore

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Thomas J. Saphner

    Recruiting

  • Baptist Health Hardin

    Elizabethtown, Kentucky, 42701

    Site Public Contact, 270-706-5470

    Mounika Mandadi

    Recruiting

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

    Site Public Contact, 410-443-1360, frank.crum@christianacare.org

    Gregory A. Masters

    Recruiting

  • Essentia Health - Ely Clinic

    Ely, Minnesota, 55731

    Site Public Contact, 218-365-7900

    Bret E. Friday

    Recruiting

  • Stanford Cancer Center Emeryville

    Emeryville, California, 94608

    Site Public Contact, 650-498-7061, ccto-office@stanford.edu

    Melinda L. Telli

    Recruiting

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

    Suspended

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

    Site Public Contact, 303-777-2663, info@westernstatesncorp.org

    Nicholas J. DiBella

    Recruiting

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

    Site Public Contact, 720-316-8091, ryan.weight@theskincancerinstitute.com

    Nicholas J. DiBella

    Recruiting

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

    Site Public Contact, 201-894-3456

    Jill S. Morrison

    Recruiting

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

    Site Public Contact, 717-721-4840

    Marianne Spengler

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Adam M. Brufsky

    Recruiting

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

    Site Public Contact, 847-570-2109

    Poornima Saha

    Recruiting

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Site Public Contact, 425-261-3529, marilyn.birchman@providence.org

    Charles W. Drescher

    Recruiting

  • Main Line Health Center-Exton

    Exton, Pennsylvania, 19341

    Suspended

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

    Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org

    Nicholas J. DiBella

    Recruiting

  • Hartford Healthcare - Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 860-972-4700, CancerResearchSupport@hhchealth.org

    Wylie D. Hosmer

    Recruiting

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Daniel S. O'Neil

    Recruiting

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

    Site Public Contact, 701-234-6161

    Daniel Almquist

    Recruiting

  • Southpointe-Sanford Medical Center Fargo

    Fargo, North Dakota, 58103

    Site Public Contact, 605-312-3320

    Daniel Almquist

    Recruiting

  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58104

    Site Public Contact, 800-437-4010

    Daniel Almquist

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Lubina Arjyal

    Recruiting

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

    Site Public Contact, 248-551-7695

    Deepa B. Jagtap

    Recruiting

  • Highlands Oncology Group - Fayetteville

    Fayetteville, Arkansas, 72703

    Site Public Contact, 479-872-8100, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Orion Cancer Care

    Findlay, Ohio, 45840

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Sujatha Murali

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Site Public Contact, 970-297-6150

    Uchenna O. Njiaju

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Site Public Contact, protocols@swog.org

    Uchenna O. Njiaju

    Recruiting

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

Other trials in United States

Puerto Rico7 sites, 7 recruiting

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060

    Site Public Contact, 787-395-7085

    Luis J. Santos Reyes

    Recruiting

  • Puerto Rico Hematology Oncology Group

    Bayamón, 00961

    Site Public Contact, 787-780-2865

    Luis J. Santos Reyes

    Recruiting

  • Doctors Cancer Center

    Manati, 00674

    Site Public Contact, 787-621-4397

    Luis J. Santos Reyes

    Recruiting

  • San Juan Community Oncology Group

    San Juan, 00917

    Site Public Contact, 787-274-3387

    Luis J. Santos Reyes

    Recruiting

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Luis J. Santos Reyes

    Recruiting

  • PROncology

    San Juan, 00927

    Site Public Contact, 787-919-7919, info@PRoncology.com

    Luis J. Santos Reyes

    Recruiting

  • San Juan City Hospital

    San Juan, 00936

    Site Public Contact, 787-763-1296

    Luis J. Santos Reyes

    Recruiting

Other trials in Puerto Rico

Mexico1 site, 1 recruiting

  • Instituto Nacional De Cancerologia de Mexico

    Mexico City, Tlalpan, 14080

    Site Public Contact, (52) 5628-0400

    Carlos A. Gonzalez-Nu��ez

    Recruiting

Other trials in Mexico

About this study

Official title: Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess whether participants with early stage triple negative breast cancer (TNBC) randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS) compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab.

SECONDARY OBJECTIVES:

  1. To compare pathological complete response (pCR) and residual cancer burden (RCB) rates by randomized arm.

II. To compare pCR and RCB rates between randomized arms by tumor infiltrating lymphocytes (TIL) status.

III. To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL enriched subgroups.

IV. To compare distant relapse-free survival and overall survival by randomized arm.

  1. To compare invasive breast cancer-free survival after surgery between randomized arms in pCR and residual disease groups.

VI. To compare the safety and tolerability by randomized arm among those that initiate therapy.

TRANSLATIONAL MEDICINE OBJECTIVE:

  1. To evaluate concordance and accuracy of an automated stromal TIL (sTIL) algorithm versus (vs.) central pathologist assessed sTILs quantification.

PATIENT REPORTED OUTCOME (PRO) OBJECTIVES:

  1. To compare patient-reported fatigue at 3 weeks after the last neoadjuvant systemic therapy (NAST) dose and, separately, at 18 months after randomization, using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-7a in participants undergoing NAST with taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy. (Quality of Life, Primary) II. To compare physical function experienced by participants undergoing neoadjuvant systemic chemotherapy (NAST) with taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy, within 3-5 weeks post last neoadjuvant systemic therapy dose using the PROMIS-29 Profile physical function subscale score. (Quality of Life, Secondary) III. To compare physical function experienced by participants undergoing NAST taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy at 18 months post registration using the PROMIS-29 Profile physical function subscale score. (Quality of Life, Secondary) IV. To compare other PROMIS-29 Profile subscale scores (sleep disturbance, depression, anxiety, social, pain interference, and pain sensitivity) and GP5 question response by arm within 3-5 weeks post last neoadjuvant systemic therapy dose and at 18 months post registration. (Quality of Life, Exploratory) V. To compare the GP-5 item scores by arm within 3-5 weeks post last neoadjuvant systemic therapy dose and at 18 months post registration. (Quality of Life, Exploratory) VI. To compare select patient-reported outcomes using the Common Terminology Criteria for Adverse Events (PRO-CTCAE) by arm. (Patient-Reported Symptoms of Treatment)

BANKING OBJECTIVE:

  1. To bank physical specimens and digital slides for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive paclitaxel intravenously (IV), carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.

ARM II: Patients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.

Patients are followed up every 6 months for the first 2 years and then annually until 5 years from registration.

Being tested
Biospecimen Collection, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given IV

  • DocetaxelDrug

    Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

    Given IV

  • DoxorubicinDrug

    Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

    Given IV

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Undergo surgery

Study groups in NCT05929768
Study groupRoleWhat they receive
Arm I (usual chemo-immunotherapy)Active comparatorPatients receive paclitaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.
Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Paclitaxel; Biological: Pembrolizumab; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Surgical Procedure
Arm II (shorter chemo-immunotherapy)ExperimentalPatients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.
Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Docetaxel; Biological: Pembrolizumab; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Surgical Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast cancer event-free survival (BC-EFS)

    Time from randomization to the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause. New non-breast primaries are not included as events. BC-EFS will be compared between the treatment arms using Cox regression with adjustment for nodal status and sTIL enrichment.

    Measured: Up to 5 years

Secondary outcomes (11)

  1. Pathologic complete response (pCR)

    pCR rates by assigned treatment arm will be compared using a difference of two proportions overall and by stromal tumor infiltrating lymphocytes (sTIL) group. Additionally, a multivariable logistic regression model will estimate the odds ratio for treatment adjusting for nodal status and sTIL group.

    Measured: From date of randomization to date of the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause, assessed up to 5 years

  2. Residual cancer burden (RCB)

    RCB 0/I rates (i.e., RCB-0 and RCB-I combined) by assigned treatment arm will be compared using a difference of two proportions overall and by sTIL group. Additionally, a multivariable logistic regression model will estimate the odds ratio for treatment adjusting for nodal status and sTIL group.

    Measured: Up to 5 years

  3. Distant relapse-free survival (DRFS)

    DRFS will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status.

    Measured: From date of randomization to date of invasive distant disease recurrence or death due to any cause, assessed up to 5 years

  4. Overall survival (OS)

    OS will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status.

    Measured: From date of randomization to date of death due to any cause, assessed up to 5 years

  5. Distant relapse-free interval (DRFI)

    DRFI will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status. Deaths not due to breast cancer will be considered competing risks in this analysis. Cumulative incidence curves will describe the two arms over the follow-up period from randomization.

    Measured: From date of randomization to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years

  6. Relapse free survival (RFS)

    RFS measured from time of surgery will compare treatment arms in a Cox regression for patients who had pCR. Nodal status and sTIL status will be included as covariates if there are sufficient numbers of events for the analysis. The expectation is that invasive breast cancer-free survival after pCR should not differ by treatment assignment.

    Measured: From time of surgery to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years

  7. RFS

    RFS measured from time of surgery will compare treatment arms in a Cox regression for patients who did not have a pCR. Nodal status and sTIL status will be included as covariates.

    Measured: From time of surgery to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years

  8. Incidence of adverse events

    Rates of adverse events will be compared between treatment arms for those initiating the assigned therapy.

    Measured: Up to 5 years

  9. Patient-Reported Fatigue

    Participant-reported fatigue will be compared between treatment arms using the Participant-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a at 3 weeks after the last neoadjuvant systemic therapy dose and at 18 months after randomization. The PROMIS Fatigue-7a is a validated 7-item questionnaire that assesses participant-reported fatigue in the past 7 days. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher T-scores indicate more fatigue.

    Measured: Up to 18 months

  10. Patient-Reported Physical Function

    Participant-reported physical function will be compared between treatment arms using the PROMIS-29 Profile v2.1 physical function subscale score at 3-5 weeks after the last neoadjuvant systemic therapy dose. The PROMIS-29 Profile is a validated 29-item questionnaire that assesses participant-reported symptoms in 9 domains. Raw scores for each subscale are converted to T-scores with a mean of 50 and a standard deviation of 10. This outcome will be assessed using the 4-item physical functioning subscale. Higher T-scores indicate greater physical function.

    Measured: Up to 5 weeks after the last neoadjuvant systemic therapy dose

  11. Patient-Reported Physical Function

    Participant-reported physical function will be compared between treatment arms using the PROMIS-29 Profile v2.1 physical function subscale score at 18 months after randomization. The PROMIS-29 Profile is a validated 29-item questionnaire that assesses participant-reported symptoms in 9 domains. Raw scores for each subscale are converted to T-scores with a mean of 50 and a standard deviation of 10. This outcome will be assessed using the 4-item physical functioning subscale. Higher T-scores indicate greater physical function.

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start15 Sep 2023
  3. Primary completion31 Mar 2033 (estimated)
  4. Study completionApr 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05929768
Sponsor's protocol ID
S2212
Other IDs
NCI-2023-02688, S2212, S2212, U10CA180888
Status last verified
Nov 2025
First submitted
1 Jun 2023
Last updated
5 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gradishar WJ, Moran MS, Abraham J, Abramson V, Aft R, Agnese D, Allison KH, Anderson B, Bailey J, Burstein HJ, Chen N, Chew H, Dang C, Elias AD, Giordano SH, Goetz MP, Jankowitz RC, Javid SH, Krishnamurthy J, Leitch AM, Lyons J, McCloskey S, McShane M, Mortimer J, Patel SA, Rosenberger LH, Rugo HS, Santa-Maria CA, Schneider BP, Smith ML, Soliman H, Stringer-Reasor EM, Telli ML, Wei M, Wisinski KB, Yellala A, Yeung KT, Young JS, Schonfeld R, Kumar R. NCCN Guidelines(R) Insights: Breast Cancer, Version 5.2025. J Natl Compr Canc Netw. 2025 Nov;23(11):426-436. doi: 10.6004/jnccn.2025.0053.

    PubMed 41213254

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biospecimen Collection, Carboplatin and Cyclophosphamide in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by SWOG Cancer Research Network at 963 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 52 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 963 sites in United States, Puerto Rico, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alicia Aranda (210-614-8808, aaranda@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast cancer event-free survival (BC-EFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05929768, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.

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