AzTrials
AzTrials

Breast CancerPhase 3OFSETNCT05879926

Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25

A Phase 3 study testing Ovarian Function Suppression + Aromatase Inhibitor and Adjuvant Chemotherapy + Ovarian Function Suppression in people with Breast Cancer, run by NRG Oncology at 1,276 sites in 9 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor… Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Ovarian Function Suppression + Aromatase Inhibitor and Adjuvant Chemotherapy + Ovarian Function Suppression
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,960 participants
Where
1,276 sitesin 9 countries
Study dates
18 Oct 2023to Jul 2034
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 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information.
  • Female patients must be greater than or equal to 18 years of age.
  • Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as:
  • Age 50 years or under with spontaneous menses within 12 months; or
  • Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or
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  • Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or
  • Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range.
  • The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 60%).
  • Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
  • Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
  • Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.
  • For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS (ductal carcinoma in situ) with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS (lobular carcinoma in situ) are eligible without additional resection.)
  • For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible if post-mastectomy RT (radiation therapy) of the chest wall will be administered.)
  • Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).
  • The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
  • By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.)
  • By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c).
  • Patients with positive isolated tumor cells (ITCs) in axillary nodes will be considered N0 for eligibility purposes.
  • Patients with micrometastatic nodal involvement (0.2-2 mm) will be considered N1.
  • Oncotype DX RS (recurrence score) requirements*:
  • If node-negative:
  • Oncotype DX RS must be RS 21-25, or
  • Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size greater than 3 cm, intermediate histologic grade with primary tumor size greater than 2 cm, or high histologic grade with primary tumor size greater than 1 cm.
  • If 1-3 nodes involved:
  • Oncotype DX RS must be less than 26.
  • Patients with a "Low Risk" or "MP1" MammaPrint (a genomic test that analyzes the activity of certain genes in early-stage breast cancer) result must have eligibility assessed with an Oncotype DX RS at pre-entry (see Section 3.1). Blocks or unstained slides must be sent to the Genomic Health centralized laboratory for testing at no cost to these patients. If MammaPrint High Risk or MP2, these patients are not eligible.
  • The tumor must be ER and/or PgR-positive (progesterone receptor) by current ASCO/CAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and/or PgR staining by IHC will be classified as positive.
  • The tumor must be HER2-negative by current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines based on local testing results.
  • The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks.
  • Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received.
  • Patients with a prior or concurrent non-breast malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. This would include prior cancers treated with curative intent.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Radiation therapy should be used according to standard guidelines; the intended radiation therapy should be declared prior to pre-entry.

Who cannot join

  • • Definitive clinical or radiologic evidence of metastatic disease.
  • pT4 (pathological state) tumors, including inflammatory breast cancer.
  • History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and/or previous DCIS or LCIS are eligible.)
  • If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer.
  • Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator.
  • Known results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values:
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  • ANC (absolute neutrophil count) less than 1200/mm3;
  • Platelet count less than 100,000/mm3;
  • Hemoglobin less than 10 g/dL;
  • Total bilirubin greater than ULN (upper limit of normal) for the lab or greater than 1.5 x ULN for patients who have a bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin;
  • AST(aspartate aminotransferase)(SGOT)/ALT (alanine transminase)(SGPT): greater than 3 × institutional ULN;
  • Renal function of GFR (glomular filtration rate) less than 30 mL/min/1.73m2.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed.
  • Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin/progesterone IUDs).
  • Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless the HBV viral load is undetectable on suppressive therapy. Patients with a history of hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured or have an undetectable HCV viral load if still on active therapy.
  • Pregnancy or lactation at the time of pre-entry. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry.)
  • Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.

Trial locations and contacts

1,276 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Director Regulatory Affairs contact

412-339-5300

langerj@nrgoncology.org

Norman Wolmark, MD contact

336 sites in 9 countries

United States300 sites, 266 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

    Suspended

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

    Site Public Contact, rohta@queens.org

    Jodi A. Kagihara

    Recruiting

  • Abbeville General Hospital

    Abbeville, Louisiana, 70510

    Site Public Contact, 337-898-6413

    Michelle M. Loch

    Recruiting

  • UM Upper Chesapeake Hematology and Oncology - Aberdeen

    Aberdeen, Maryland, 21001

    Active, not recruiting

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

    Site Public Contact, 605-622-8700, oncregulatory@avera.org

    Jason M. Jones

    Recruiting

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

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

    Dan S. Zuckerman

    Recruiting

  • 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

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

    Site Public Contact, 866-223-8100, CancerAnswer@ccf.org

    Halle C. Moore

    Recruiting

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

    Site Public Contact, 229-312-0405, ga_cares@augusta.edu

    Anand P. Jillella

    Recruiting

  • Atrium Health Stanly/LCI-Albemarle

    Albemarle, North Carolina, 28002

    Site Public Contact, 800-804-9376

    Julie G. Fisher

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Jacklyn M. Nemunaitis

    Recruiting

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

    Site Public Contact, 505-559-6113, WBurman@phs.org

    Jacklyn M. Nemunaitis

    Recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

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

    Elie G. Dib

    Recruiting

  • Saint Luke's Cancer Center - Allentown

    Allentown, Pennsylvania, 18104

    Active, not 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

    Elie G. Dib

    Recruiting

  • MyMichigan Medical Center Alpena

    Alpena, Michigan, 49707

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

    Elie G. Dib

    Recruiting

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

    Site Public Contact, 407-303-2200

    Wassim Mchayleh

    Recruiting

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Site Public Contact, 618-463-5623

    Jay W. Carlson

    Recruiting

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

    Site Public Contact, 806-212-1985, Gina.Cravey@bsahs.org

    Anita Ravipati

    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

    Dan S. Zuckerman

    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

    Dan S. Zuckerman

    Recruiting

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

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

    Dan S. Zuckerman

    Recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

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

    Dan S. Zuckerman

    Recruiting

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Suspended

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

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

    Dan S. Zuckerman

    Recruiting

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

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

    Dan S. Zuckerman

    Recruiting

  • UTMB Health Angleton Danbury Campus

    Angleton, Texas, 77515

    Suspended

  • 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

    Elie G. Dib

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Kathleen A. Kemmer

    Recruiting

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

    Active, not recruiting

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

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

    Andrew J. Huang

    Recruiting

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

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

    Shannon Schmidt

    Recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

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

    Loretta J. Nastoupil

    Recruiting

  • PCR Oncology

    Arroyo Grande, California, 93420

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

    Khawaja S. Jahangir

    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

  • King's Daughter's Medical Center

    Ashland, Kentucky, 41101

    Site Public Contact, 606-327-6499

    David K. Goebel

    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

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

    Site Public Contact, research@universitycancer.com

    Anand P. Jillella

    Recruiting

  • OhioHealth O'Bleness Hospital

    Athens, Ohio, 45701

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Kevin M. Kalinsky

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Kevin M. Kalinsky

    Recruiting

  • Piedmont Hospital

    Atlanta, Georgia, 30309

    Site Public Contact, 404-425-7943, ORS@piedmont.org

    Adam W. Nowlan

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Kevin M. Kalinsky

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Kevin M. Kalinsky

    Recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-303-3355, ClinicalTrials@northside.com

    Amelia B. Zelnak

    Recruiting

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, Georgia, 30901

    Site Public Contact, 706-821-2944

    Anand P. Jillella

    Recruiting

  • Augusta Oncology Associates PC-Wheeler

    Augusta, Georgia, 30909

    Site Public Contact, 706-736-1830

    Anand P. Jillella

    Recruiting

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

    Site Public Contact, 207-626-4855

    Michael Auster

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Virginia F. Borges

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Suspended

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

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

    Oleg Gligich

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Site Public Contact, 954-461-2180

    Frances Valdes-Albini

    Recruiting

  • Hartford HealthCare - Avon

    Avon, Connecticut, 06001

    Site Public Contact, 860-972-4700

    Rajvi Patel

    Recruiting

  • IU Health West Hospital

    Avon, Indiana, 46123

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

    Tarah J. Ballinger

    Recruiting

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

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

    Elie G. Dib

    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

  • Mercy Medical Center

    Baltimore, Maryland, 21202

    Site Public Contact, 410-951-7956, acline@mdmercy.com

    David A. Riseberg

    Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Site Public Contact, 443-849-3706

    Robert B. Donegan

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Site Public Contact, 410-601-9083

    Wilfred Layne

    Recruiting

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

    Site Public Contact, 443-777-7364

    Kristen D. Whitaker

    Recruiting

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

    Site Public Contact, 410-261-8151, Barbara.rector@medstar.net

    Kristen D. Whitaker

    Recruiting

  • Kaiser Permanente-Woodlawn Medical Center

    Baltimore, Maryland, 21244

    Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org

    James Liu

    Recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Site Public Contact, 410-955-8804, jhcccro@jhmi.edu

    Jennifer Y. Sheng

    Recruiting

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

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

    Bradley T. Clifford

    Recruiting

  • CommonSpirit Saint Joseph Hospital - Bardstown

    Bardstown, Kentucky, 40004

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

    Loretta J. Nastoupil

    Recruiting

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Thomas J. Saphner

    Recruiting

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Victor T. Lin

    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

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

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

    Lubina Arjyal

    Recruiting

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

    Site Public Contact, 516-734-8896

    Brittney S. Zimmerman

    Recruiting

  • Houston Methodist San Jacinto Hospital

    Baytown, Texas, 77521

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Sindhu Nair

    Recruiting

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

    Active, not recruiting

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

    Active, not recruiting

  • MedStar Health Bel Air Medical Campus

    Bel Air, Maryland, 21015

    Site Public Contact, David.j.perry2@medstar.net

    Kristen D. Whitaker

    Recruiting

  • MaineHealth Waldo Hospital

    Belfast, Maine, 04915

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Michael Auster

    Recruiting

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

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

    Samia Asif

    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, achapman1@peacehealth.org

    Dan S. Zuckerman

    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

    Dan S. Zuckerman

    Recruiting

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • ThedaCare Cancer Care - Berlin

    Berlin, Wisconsin, 54923

    Site Public Contact, 920-364-3605, ResearchDept@thedacare.org

    Shannon Schmidt

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Kara K. Landry

    Recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

    Site Public Contact, 301-319-2100

    Jeremy G. Perkins

    Recruiting

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

    Active, not recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

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

    Elie G. Dib

    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

    Maria Galkin

    Recruiting

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

    Site Public Contact, towercancerresearch@toweroncology.com

    Yuan Yuan

    Recruiting

  • MaineHealth Maine Medical Center - Biddeford

    Biddeford, Maine, 04005

    Suspended

  • 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

    Alicia Swink

    Recruiting

  • Intermountain Health West End Clinic

    Billings, Montana, 59106

    Site Public Contact, 406-238-6685

    Alicia Swink

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Active, not recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

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

    Daniel Almquist

    Recruiting

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

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

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

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

    Bryan A. Faller

    Recruiting

  • MUSC Health - Bluffton Medical Pavilion

    Bluffton, South Carolina, 29910

    Site Public Contact, 843-792-2300, hcc-clinical-trials@musc.edu

    Frank J. Brescia

    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

    Active, not 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

    Elie G. Dib

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

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

    Dan S. Zuckerman

    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

    Suspended

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org

    Don S. Dizon

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Site Public Contact, 617-667-9925

    Shana Berwick

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Erica L. Mayer

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

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

    John M. Schallenkamp

    Recruiting

  • Florida Cancer Specialists - Bradenton Cancer Center

    Bradenton, Florida, 34205

    Site Public Contact, 239-274-9930, clinicaltrials@flcancer.com

    Pavankumar Tandra

    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

    Rajvi Patel

    Recruiting

  • United Hospital Center

    Bridgeport, West Virginia, 26330

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Bei Jiang

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

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

    Elie G. Dib

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

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

    Elie G. Dib

    Recruiting

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    Kathleen A. Kemmer

    Recruiting

  • New York-Presbyterian Westchester Hospital

    Bronxville, New York, 10708

    Suspended

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Site Public Contact, 718-780-3677, Adg9003@nyp.org

    Evelyn O. Taiwo

    Recruiting

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

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

    Nina D'Abreo

    Recruiting

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

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

    Haythem Y. Ali

    Recruiting

  • Mid Coast Hospital

    Brunswick, Maine, 04011

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Michael Auster

    Recruiting

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

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

    Arezoo Ghaneie

    Recruiting

  • Keck Medicine of USC Buena Park

    Buena Park, California, 90621

    Site Public Contact, 714-522-0908

    Daphne B. Stewart

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Ellis G. Levine

    Recruiting

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

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

    Dan S. Zuckerman

    Recruiting

  • Kaiser Permanente-Burke Medical Center

    Burke, Virginia, 22015

    Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org

    James Liu

    Recruiting

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Lahey Clinic

    Burlington, Massachusetts, 01805

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

    Maria Galkin

    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

    Joleen M. Hubbard

    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

    Alicia Swink

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

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

    Elie G. Dib

    Recruiting

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    Site Public Contact, 856-325-6757

    Danny Markabawi

    Recruiting

  • Marshall Cancer Center

    Cameron Park, California, 95682

    Site Public Contact, 530-672-7050, cancerservices@marshallmedical.org

    Helen K. Chew

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    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

    Elie G. Dib

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

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

    Elie G. Dib

    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

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Marija Balic

    Recruiting

  • IU Health North Hospital

    Carmel, Indiana, 46032

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

    Tarah J. Ballinger

    Recruiting

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

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

    Loretta J. Nastoupil

    Recruiting

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

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

    Loretta J. Nastoupil

    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

    Khawaja S. Jahangir

    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

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

    Site Public Contact, NCTNStudyTeam@dm.duke.edu

    Alexandra Thomas

    Recruiting

  • UNC Health Cancer Care Cary

    Cary, North Carolina, 27518

    Site Public Contact, 919-784-2500, CancCtrOncologyClinicalResearch@unchealth.unc.edu

    Elizabeth C. Dees

    Recruiting

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

    Site Public Contact, 919-350-1700, TCHILDRESS@wakemed.org

    Pallavi Kopparthy

    Recruiting

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    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

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Active, not 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

    Suspended

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

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

    Dan S. Zuckerman

    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, 412-339-5294, Roster@nrgoncology.org

    Marianne Spengler

    Recruiting

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

    Site Public Contact, 717-217-6020

    Marianne Spengler

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

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

    Yara Abdou

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Frank J. Brescia

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Julie G. Fisher

    Recruiting

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Kimberly S. Strickland

    Recruiting

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

    Site Public Contact, 980-442-2000

    Julie G. Fisher

    Recruiting

  • Levine Cancer Institute-SouthPark

    Charlotte, North Carolina, 28211

    Site Public Contact, 980-442-2000

    Julie G. Fisher

    Recruiting

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

    Site Public Contact, 800-804-9376

    Julie G. Fisher

    Recruiting

  • Levine Cancer Institute-Ballantyne

    Charlotte, North Carolina, 28277

    Site Public Contact, 800-804-9376

    Julie G. Fisher

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

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

    Trish Millard

    Recruiting

  • Minnesota Oncology Hematology PA-Chaska

    Chaska, Minnesota, 55318

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

    Joleen M. Hubbard

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

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

    Elie G. Dib

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

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

    Elie G. Dib

    Recruiting

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

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

    Kathleen Degen

    Recruiting

  • Memorial Hospital of Laramie County

    Cheyenne, Wyoming, 82001

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    John M. Schallenkamp

    Recruiting

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

    Site Public Contact, 773-257-5960, suhi@sinai.org

    Pam G. Khosla

    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

    Ruta D. Rao

    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

    Frederick M. Howard

    Recruiting

  • Northwestern Medicine Cancer Center Old Irving Park

    Chicago, Illinois, 60641

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Lisa E. Flaum

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Thomas J. Saphner

    Recruiting

  • Enloe Medical Center

    Chico, California, 95926

    Site Public Contact, 530-332-4700

    Helen K. Chew

    Recruiting

  • Enloe Cancer Center

    Chico, California, 95928

    Site Public Contact, 530-332-3858, clinicalresearchteam@enloe.org

    Helen K. Chew

    Recruiting

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

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

    Patcharin Tanawattanacharoen

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-585-0844

    Jennifer B. Manders

    Recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

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

    Loretta J. Nastoupil

    Recruiting

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

    Active, not recruiting

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

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

    Loretta J. Nastoupil

    Recruiting

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

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

    Loretta J. Nastoupil

    Recruiting

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

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

    Loretta J. Nastoupil

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

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

    Lindsay L. Peterson

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

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

    Dan S. Zuckerman

    Recruiting

  • Kaiser Sunnyside Medical Center

    Clackamas, Oregon, 97015

    Suspended

  • 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

    Elie G. Dib

    Recruiting

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

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

    Lubina Arjyal

    Recruiting

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Trinity Health IHA Medical Group - Primary Care - Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 248-858-6215, Emily.Crofts@Trinity-Health.org

    Elie G. Dib

    Recruiting

  • Morton Plant Hospital

    Clearwater, Florida, 33756

    Site Public Contact, 855-314-8646

    Vijaya K. Gadiyaram

    Recruiting

  • Novant Health Colon and Rectal Clinic

    Clemmons, North Carolina, 27012

    Site Public Contact, 336-718-8335, pjordan@novanthealth.org

    Judith O. Hopkins

    Recruiting

  • Wake Forest University at Clemmons

    Clemmons, North Carolina, 27012

    Site Public Contact, 888-716-9259

    Emily H. Douglas

    Recruiting

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Halle C. Moore

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Halle C. Moore

    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, 515-241-3305

    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

  • Saint Luke's Hospital-Miners Campus

    Coaldale, Pennsylvania, 18218

    Active, not 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

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

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

    Amna Khattak

    Recruiting

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

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

    Loretta J. Nastoupil

    Recruiting

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

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

    Loretta J. Nastoupil

    Recruiting

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Virginia F. Borges

    Recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Site Public Contact, 719-364-6700

    Virginia F. Borges

    Recruiting

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

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

    Loretta J. Nastoupil

    Recruiting

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-7440

    Puja Nistala

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

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

    Amna Khattak

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

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

    Nicole O. Williams

    Recruiting

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

    Active, not recruiting

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Site Public Contact, 800-804-9376

    Julie G. Fisher

    Recruiting

  • UT MD Anderson - The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Vicente Valero

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

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

    Joleen M. Hubbard

    Recruiting

  • Minnesota Oncology - Coon Rapids

    Coon Rapids, Minnesota, 55433

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

    Joleen M. Hubbard

    Recruiting

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Suspended

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Frances Valdes-Albini

    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

    Loretta J. Nastoupil

    Recruiting

  • NYP/Hudson Valley Hospital

    Cortlandt Manor, New York, 10567

    Site Public Contact, 877-697-9355

    Natalie S. Berger

    Recruiting

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

    Suspended

  • Mary Bird Perkins Cancer Center - Covington

    Covington, Louisiana, 70433

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Victor T. Lin

    Recruiting

  • Ochsner Hematology Oncology North Shore - Covington (West Region)

    Covington, Louisiana, 70433

    Active, not recruiting

  • UPMC Hillman Cancer Center - Passavant - Cranberry

    Cranberry Township, Pennsylvania, 16066

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

    Marija Balic

    Recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Suspended

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

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

    Lindsay L. Peterson

    Recruiting

  • Essentia Health - Saint Joseph's Crosslake Clinic

    Crosslake, Minnesota, 56442

    Site Public Contact, 218-692-1010

    Bret E. Friday

    Recruiting

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

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

    Frederick M. Howard

    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

  • Houston Methodist Cypress Hospital

    Cypress, Texas, 77429

    Site Public Contact, 346-356-1413, irb@houstonmethodist.org

    Sindhu Nair

    Recruiting

  • MaineHealth LincolnHealth Hospital

    Damariscotta, Maine, 04543

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Michael Auster

    Recruiting

  • Danbury Hospital

    Danbury, Connecticut, 06810

    Site Public Contact, 833-223-4732

    George F. Zahrah

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

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

    Pratima Chalasani

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

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

    Jennifer R. Collins

    Recruiting

  • Sutter Davis Hospital

    Davis, California, 95616

    Site Public Contact, NCIclinicaltrials@sutterhealth.org

    Kristie A. Bobolis

    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

    Active, not 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

    Suspended

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

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

    Haythem Y. Ali

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

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

    Kevin M. Kalinsky

    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

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Frances Valdes-Albini

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

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

    Lisa E. Flaum

    Recruiting

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Shakir Sarwar

    Recruiting

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

    Suspended

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Virginia F. Borges

    Recruiting

  • AdventHealth Porter

    Denver, Colorado, 80210

    Suspended

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

    Site Public Contact, 303-318-3413

    Alicia Swink

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

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

    Maryam B. Lustberg

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

Other trials in United States

Canada12 sites, 12 recruiting

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

    Site Public Contact, 705-739-5661

    Sara J. Rask

    Recruiting

  • Waterloo Regional Health Network

    Kitchener, Ontario, N2G 1G3

    Site Public Contact, 519-749-4370, research@wrhn.ca

    Nadia B. Califaretti

    Recruiting

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

    Site Public Contact, 519-685-8600

    Veera Durga S. Panuganty

    Recruiting

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Site Public Contact, 514-890-8000 ext. 12725, info.cr.chum@ssss.gouv.qc.ca

    Saima Hassan

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Site Public Contact, 514-340-8222 ext. 8248

    Parvaneh Fallah

    Recruiting

  • Oakville Trafalgar Memorial Hospital

    Oakville, Ontario, L6M 0L8

    Site Public Contact, 905-338-4635

    Michael Herman

    Recruiting

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

    Site Public Contact, 905-576-8711 ext. 4258

    Gursimran Chandhoke

    Recruiting

  • CHU de Quebec-Hopital du Saint-Sacrement (HSS)

    Québec, Quebec, G1S 4L8

    Site Public Contact, 418-649-5593, jbegin@uresp.ulaval.ca

    Claudya Morin

    Recruiting

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

    Site Public Contact, 306-766-2213

    Haji I. Chalchal

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

    Site Public Contact, 306-655-2914

    Shahid Ahmed

    Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

    Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca

    Michel Pavic

    Recruiting

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Site Public Contact, 416-480-5000

    Carlos A. Carmona Gonzalez

    Recruiting

Other trials in Canada

Japan12 sites, 12 recruiting

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

    Site Public Contact, 81 78-929-1151

    Koji Matsumoto

    Recruiting

  • Gunma University Hospital

    Gunma, Maebashi, 371-8511

    Site Public Contact, 81-27-220-7626

    Sayaka Obayashi

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551

    Site Public Contact, 82-424-6042

    Hideo Shigematsu

    Recruiting

  • The Cancer Institute Hospital Of JFCR

    Koto-ku, Tokyo, 135-8550

    Site Public Contact, gog-jpn@insti.kitasato-u.ac.jp

    Yukinori Ozaki

    Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    Site Public Contact, 81-75-751-3111

    Norikazu Masuda

    Recruiting

  • Shikoku Cancer Center

    Matsuyama, 791-0280

    Site Public Contact, 089-999-1172

    Daisuke Takabatake

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Tadahiko Shien

    Recruiting

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

    Site Public Contact, 81-49-276-2028

    Akihiro Fujimoto

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Site Public Contact, hassi@med.hokudai.ac.jp

    Tomohiro Oshino

    Recruiting

  • Nagoya University Hospital

    Showa-Ku Nagoya, 466-0065

    Site Public Contact, 81 52-741-2111

    Masayuki Nagahashi

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104 0045

    Site Public Contact, 81-3-3542-2511, www-admin@ncc.go.jp

    Shin Takayama

    Recruiting

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

    Site Public Contact, (081) 089-964-5111

    Yoshiaki Kamei

    Recruiting

Other trials in Japan

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, 412-339-5294, Roster@nrgoncology.org

    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

Colombia1 site

  • Instituto Nacional De Cancerologia

    Bogotá, 99999

    Suspended

Other trials in Colombia

Mexico1 site, 1 recruiting

  • Instituto Nacional De Cancerologia de Mexico

    Mexico City, Tlalpan, 14080

    Site Public Contact, (52) 5628-0400

    Areli Velazquez Martinez

    Recruiting

Other trials in Mexico

Peru1 site

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

    Suspended

Other trials in Peru

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 110-744

    Site Public Contact, 011-82-760-2384

    Hyeong-Gon Moon

    Recruiting

Other trials in South Korea

Uruguay1 site, 1 recruiting

  • Hospital de Clinicas Dr Manuel Quintela

    Montevideo, 11600

    Site Public Contact, 598 2 4000101 X 1934, comunicaciones@msp.gub.uy

    Cecilia Castillo

    Recruiting

Other trials in Uruguay

About this study

Official title: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Read the detailed description

Younger age at diagnosis is an adverse prognostic factor in early breast cancer: women who are less than 35 years of age at diagnosis are more likely to die from their disease than their older counterparts following standard treatments. There remains a pressing need for advancements in therapeutic options for this patient population. One increasingly utilized option is ovarian suppression, which was first reported as treatment for advanced breast cancer in 1896 and has been examined in a multitude of clinical trials over the past century. As chemotherapeutic options became more commonplace for breast cancer therapy, however, the role of ovarian suppression became uncertain.

In the pre-genomic era, several studies evaluated the role of ovarian suppression compared to chemotherapy, with conflicting results. These studies either looked at ovarian suppression alone or at tamoxifen compared to chemotherapy. A meta-analysis examining LHRH-agonists (luteinizing hormone-releasing hormone) in the Early Breast Cancer Overview group (LHRH-agonists in Early Breast Cancer Overview group 2007) showed that when LHRH-agonists were added to tamoxifen, chemotherapy, or both, there was a 12.7% reduction in the risk of recurrence and a 15.1% reduction in the risk of death. When compared to chemotherapy, LHRH-agonists appeared to be equally as effective, especially if patients were less than 40 years of age. These older studies, conducted in the pre-taxane/anthracycline era, typically used CMF (cyclophosphamide, methotrexate, and fluorouracil) chemotherapy, and were designed prior to the use of genomic assays .

Conditions
Breast Cancer
Being tested
Ovarian Function Suppression + Aromatase Inhibitor, Adjuvant Chemotherapy + Ovarian Function Suppression
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Ovarian Function Suppression + Aromatase InhibitorDrug

    Aromatase inhibitor co-administered with a GnRH agonist for 5 years. The choice of AI is per investigator discretion. The choice of GnRH agonist and dosing schedule is per investigator's discretion. Options commonly include goserelin, leuprolide, or triptorelin given monthly or every-three-months. The dose and schedule of AI should be consistent with the drug package insert. Endocrine treatment beyond 5 years is at the investigator's discretion. Bilateral oophorectomy may substitute for ovarian suppression if desired.

  • Adjuvant Chemotherapy + Ovarian Function SuppressionDrug

    Adjuvant chemotherapy of investigator's choice followed by an aromatase inhibitor (AI) co-administered with an GnRH agonist for 5 years. The choice of AI is per investigator discretion. The choice of GnRH agonist and dosing schedule is per investigator's discretion. Options commonly include goserelin, leuprolide, or triptorelin given monthly or every-three-months. The dose and schedule of AI should be consistent with the drug package insert. Endocrine treatment beyond 5 years is at the investigator's discretion. Bilateral oophorectomy may substitute for ovarian suppression if desired.

Study groups in NCT05879926
Study groupRoleWhat they receive
Arm 1: Ovarian Function Suppression + Aromatase InhibitorActive comparatorAromatase inhibitor co-administered with a GnRH agonist (gonadotropin releasing hormone) for 5 years. The choice of AI is per investigator discretion. The choice of GnRH agonist and dosing schedule is per investigator's discretion. Options commonly include goserelin, leuprolide, or triptorelin given monthly or every-three-months. The dose and schedule of AI should be consistent with the drug package insert. Endocrine treatment beyond 5 years is at the investigator's discretion. Bilateral oophorectomy may substitute for ovarian suppression if desired.
Receives: Drug: Ovarian Function Suppression + Aromatase Inhibitor
Arm 2 Adjuvant Chemotherapy + Ovarian Function Suppression + Aromatase InhibitorActive comparatorAdjuvant chemotherapy of investigator's choice followed by an aromatase inhibitor (AI) co-administered with an GnRH agonist for 5 years. The choice of AI is per investigator discretion. The choice of GnRH agonist and dosing schedule is per investigator's discretion. Options commonly include goserelin, leuprolide, or triptorelin given monthly or every-three-months. The dose and schedule of AI should be consistent with the drug package insert. Endocrine treatment beyond 5 years is at the investigator's discretion. Bilateral oophorectomy may substitute for ovarian suppression if desired.
Receives: Drug: Ovarian Function Suppression + Aromatase Inhibitor; Drug: Adjuvant Chemotherapy + Ovarian Function Suppression

What is being measured

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

  1. Invasive breast cancer-free survival (IBCFS)

    Time from randomization to the first diagnosis of local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause prior to recurrence or contralateral breast cancer.

    Measured: Time from randomization for duration of trial, 11 years

Secondary outcomes (6)

  1. Invasive disease-free survival (IDFS)

    Time from randomization to the first diagnosis of local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause prior to recurrence or second primary cancer.

    Measured: Time from randomization for duration of trial, 11 years

  2. Overall survival

    Time from randomization to death from any cause

    Measured: Time from randomization for duration of trial, 11 years

  3. Distant recurrence-free interval (DRFI)

    Time from randomization until the first diagnosis of distant metastasis or death from breast cancer, regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancers. This endpoint is censored at the time of death from causes other than breast cancer.

    Measured: Time from randomization for duration of trial, 11 years

  4. Breast cancer-free interval (BCFI)

    Time from randomization until the first diagnosis of local invasive recurrence, regional recurrence, distant recurrence, contralateral breast cancer or death from breast cancer.

    Measured: Time from randomization for duration of trial, 11 years

  5. Menopausal symptoms measured by the FACT ESS-19 score

    The FACT-ES 19 Item Endocrine Symptom Subscale (ESS-19) score. The score is calculated as a sum of 19 endocrine symptom items. The score range is 0-76 and a higher score indicates better QOL.

    Measured: Measured at one year after randomization

  6. Pain during aromatase inhibitor (AI) therapy

    The pain severity question from the PROMIS-29 Profile. Pain will be measured on a 0-10 scale using the pain questions from the PROMIS-29 profile.

    Measured: Measured at one year after randomization

Timeline

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

  1. First posted30 May 2023
  2. Study start18 Oct 2023
  3. Primary completionJan 2032 (estimated)
  4. Study completionJul 2034 (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
3,960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05879926
Sponsor's protocol ID
NRG-BR009
Other IDs
5U10CA180868-07, NCI-2023-04529
Acronym
OFSET
Status last verified
Nov 2026
First submitted
19 May 2023
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ovarian Function Suppression + Aromatase Inhibitor and Adjuvant Chemotherapy + Ovarian Function Suppression in people with Breast Cancer, run by NRG Oncology at 1,276 sites in 9 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 34 inclusion and 19 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,276 sites in United States, Canada, Japan, Puerto Rico, Colombia and 4 more countries. 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 Director Regulatory Affairs (412-339-5300, langerj@nrgoncology.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive breast cancer-free survival (IBCFS) (time frame: Time from randomization for duration of trial, 11 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 NCT05879926.

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 4 Nov 2026.

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