Anatomic Stage II Breast Cancer AJCC v8Phase 3NCT05812807
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
A Phase 3 study testing Pembrolizumab, Patient Observation and Biopsy in people with Anatomic Stage II Breast Cancer AJCC v8 and Early Stage Triple-Negative Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 846 sites in 3 countries.
Trial summary
This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage II Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma, Anatomic Stage IIIA Breast Cancer AJCC v8
- What is being tested?
- Pembrolizumab, Patient Observation and Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,295 participants
- Where
- 846 sitesin 3 countries
- Study dates
- 14 Jun 2023to 31 May 2033
- Phase
- Phase 3
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
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Triple Negative Breast Cancer:
- Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of diagnosis according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both
- Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative
- Estrogen receptor (ER) and progesterone receptor (PR) =< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] and fluorescence in situ hybridization [FISH])
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- If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts
- Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively
- An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization
- Note: Adjuvant radiation can be given on study, however, it is recommended to complete adjuvant radiation prior to registration. If radiation is given on study, it is encouraged to be given concurrently with pembrolizumab if the patient is on the pembrolizumab arm, per investigator discretion. Treatment with adjuvant pembrolizumab is strongly discouraged prior to participation in this trial, but if administered (e.g., if patients are awaiting pathology results), pembrolizumab may be administered for up to 6 weeks (i.e., up to 2 q3week doses or up to one q6week dose) post-surgery and must be completed prior to registration post-surgery and must be completed prior to registration
- Use of investigational anti-cancer agents must be discontinued at time of registration
- Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
- Breast surgery: Total mastectomy or breast-conserving surgery with histologically negative margins, including no ink on tumor for DCIS, at the time of excision
- For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of ductal carcinoma in-situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates DCIS at the line of resection, additional operative procedures may be performed to obtain clear margins. If DCIS is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
- Lymph node surgery:
- For a patient with clinically N0 disease, a sentinel lymph node biopsy should have been performed at time of surgical evaluation, and if pathologically node positive, the patient is no longer eligible. Isolated tumor cells are considered node-negative
- For a patient with clinically N1 disease at diagnosis (with positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy) additional surgical evaluation of the axilla following preoperative therapy is required
- If they become cN0 (no palpable adenopathy), then a sentinel lymph node biopsy could have been performed at time of surgery (axillary dissection would also be permitted); if the sentinel lymph node biopsy is positive, the patient is no longer eligible
- If sentinel node biopsy performed before preoperative therapy was negative, no additional surgical evaluation of the axilla is required after preoperative therapy. If sentinel node biopsy performed before preoperative therapy was positive, an ALND is required after preoperative therapy
- If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is still required
- If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required
- Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy
- If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible
- Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 7 days prior to randomization is required
- Absolute neutrophil count (ANC) >= 1,000/mm^3
- Platelet Count >= 100,000/mm^3
- Estimated glomerular filtration rate (eGFR) >= 15 mL/min/1.73m^2
- Total Bilirubin =<1.5 x upper limit of normal (ULN)
- Patients with Gilbert's disease with a total bilirubin =< 2.5 x ULN and direct bilirubin within normal limits are permitted
- Aspartate aminotransferase (AST) serum aspartate aminotransferase [SGOT] / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase [SGPT] =< 3 x institutional ULN
- Patients must be willing to provide tumor tissue from the diagnostic core biopsy. If inadequate tumor tissue is available, patients are still eligible to participate in the trial
- Patients with a prior or concurrent 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
- 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
- Patients with known HIV infection who are on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
Who cannot join
- No stage IV (metastatic) breast cancer
- No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed
- No evidence of recurrent disease following preoperative therapy and surgery
- No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis
- No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product
- Note: Prior immune-related adverse events (irAEs) are allowed if they resolved to ≤ grade 1 and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE. The following are exceptions to this criterion: Grade 2 or lower immune mediated endocrinopathies due to neoadjuvant checkpoint inhibition but patients are stable on endocrine therapy and were able to continue checkpoint inhibition.
- No medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy
- Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible
Trial locations and contacts
846 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
318 sites in 3 countries
United States300 sites, 277 recruiting
- Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-539-2273, info@hawaiicancercare.com
Jami A. Fukui
- Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Site Public Contact, 808-486-6000
Jami A. Fukui
- Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Site Public Contact, rohta@queens.org
Jami A. Fukui
- Recruiting
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, 57401
Site Public Contact, 605-622-8700, oncregulatory@avera.org
Alexandra Higgins
- Recruiting
Summa Health System - Akron Campus
Akron, Ohio, 44304
Site Public Contact, 330-375-4221, cancerresearch@summahealth.org
Bradley T. Clifford
- Suspended
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
- Recruiting
Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina, 28002
Site Public Contact, 800-804-9376
Ashley G. Matusz-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
- Active, not recruiting
AdventHealth Altamonte
Altamonte Springs, Florida, 32701
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- 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
Elie G. Dib
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Monika L. Burness
- Recruiting
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401
Site Public Contact, 443-481-1320, research@luminishealth.org
Young J. Lee
- 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
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Shannon Schmidt
- Recruiting
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin, 54915
Site Public Contact, AWRI.inquiry@ascension.org
Jonathan S. Treisman
- 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
- Suspended
Cone Health Cancer Center at Asheboro
Asheboro, North Carolina, 27203
- Recruiting
Cone Health MedCenter Asheboro
Asheboro, North Carolina, 27205
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
University Cancer and Blood Center LLC
Athens, Georgia, 30607
- Recruiting
OhioHealth O'Bleness Hospital
Athens, Ohio, 45701
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-778-1868
Jane L. Meisel
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Jane L. Meisel
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Jane L. Meisel
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Jane L. Meisel
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-303-3355, ClinicalTrials@northside.com
Amelia B. Zelnak
- Suspended
Augusta Oncology Associates PC-D'Antignac
Augusta, Georgia, 30901
- Suspended
Augusta Oncology Associates PC-Wheeler
Augusta, Georgia, 30909
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Marie E. Wood
- 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
- Active, not recruiting
IU Health West Hospital
Avon, Indiana, 46123
- Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Site Public Contact, 800-641-2422
Takae Mizukami
- 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
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
Yvonne L. Ottaviano
- Recruiting
Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland, 21244
Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org
James Liu
- Recruiting
Summa Health System - Barberton Campus
Barberton, Ohio, 44203
Site Public Contact, 330-375-4221, cancerresearch@summahealth.org
Bradley T. Clifford
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Thomas J. Saphner
- Suspended
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
- Suspended
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
- Recruiting
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816
Site Public Contact, 225-761-5346, Camille.Beck@Ochsner.org
Caitlin Taylor
- Suspended
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70817
- Recruiting
Ochsner High Grove
Baton Rouge, Louisiana, 70836
Site Public Contact, 225-761-5346, Camielle.beck@ochsner.org
Caitlin Taylor
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- 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, 773-702-9171, protocols@AllianceNCTN.org
Kai Sun
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Takae Mizukami
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Amulya Yellala
- Recruiting
FHCC Overlake
Bellevue, Washington, 98004
Site Public Contact, 425-454-2148
Goldy Bansal
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- 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
Alison K. Conlin
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- 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
Peter A. Kaufman
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Site Public Contact, 301-319-2100
Jeremy G. Perkins
- 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
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
- Active, not recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
- 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
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
Alison K. Conlin
- Recruiting
Schulze Family Foundation Cancer Clinic - Bonita Health Center
Bonita Springs, Florida, 34135
Site Public Contact, 239-343-9660, RCCR@leehealth.org
Janine Harewood
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Anubha Bharthuar
- 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
Nadine M. Tung
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Sara M. Tolaney
- 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
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606
Site Public Contact, 860-972-4700
Alvaro G. Menendez
- 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
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin, 53045
Site Public Contact, AWRI.Inquiry@Ascension.org
Jonathan S. Treisman
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Site Public Contact, 718-765-2500
Susan Burdette-Radoux
- Recruiting
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220
Site Public Contact, 646-754-4624, david.wallach@nyulangone.org
Natalie J. Klar
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Ellis G. Levine
- 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
Peter A. Kaufman
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Peter A. Kaufman
- 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
Yan Ji
- 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
Mili Arora
- Recruiting
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, 13031
Site Public Contact, 315-472-7504
Steven M. Duffy
- 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
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Active, not recruiting
IU Health North Hospital
Carmel, Indiana, 46032
- 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, 720-874-1881, ResearchInstituteInquiries@commonspirit.org
Shahzad Siddique
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- 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
- Active, not recruiting
UNC Health Cancer Care Cary
Cary, North Carolina, 27518
- Recruiting
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Site Public Contact, 319-297-2900
Bharat Jenigiri
- 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
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
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
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
Ashley G. Matusz-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
Ashley G. Matusz-Fisher
- Recruiting
Levine Cancer Institute-SouthPark
Charlotte, North Carolina, 28211
Site Public Contact, 980-442-2000
Ashley G. Matusz-Fisher
- Recruiting
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
Site Public Contact, 800-804-9376
Ashley G. Matusz-Fisher
- Recruiting
Levine Cancer Institute-Ballantyne
Charlotte, North Carolina, 28277
Site Public Contact, 800-804-9376
Ashley G. Matusz-Fisher
- 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
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
William J. Gradishar
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Deimante M. Tamkus
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Abiola Ibraheem
- 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
Nan Chen
- 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
Mili Arora
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin, 53014
Site Public Contact, AWRI.inquiry@ascension.org
Jonathan S. Treisman
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Kerri McGovern
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
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
Nusayba Bagegni
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Morton Plant Hospital
Clearwater, Florida, 33756
Site Public Contact, 855-314-8646
Vijaya K. Gadiyaram
- Recruiting
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012
Site Public Contact, 888-716-9259
Katherine Ansley
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Takae Mizukami
- Recruiting
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735
Site Public Contact, 301-877-4673
Ami Chitalia
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- 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
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
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Marie E. Wood
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Marie E. Wood
- 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
Margaret E. Gatti-Mays
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
Grant Medical Center
Columbus, Ohio, 43215
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Doctors Hospital
Columbus, Ohio, 43228
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Site Public Contact, 603-224-2556
Josy Mathew
- Recruiting
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Site Public Contact, 800-804-9376
Ashley G. Matusz-Fisher
- Recruiting
UT MD Anderson - The Woodlands
Conroe, Texas, 77384
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Clinton Yam
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Baptist Health Corbin
Corbin, Kentucky, 40701
Site Public Contact, 859-523-1934
Mounika Mandadi
- Recruiting
Guthrie Cortland Memorial Hospital
Cortland, New York, 13045
Site Public Contact, 607-756-3130
Alina Basnet
- Suspended
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503
- Suspended
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
- Suspended
Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
Council Bluffs, Iowa, 51503
- Recruiting
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433
Site Public Contact, 985-809-5668, Cheryl.kesler@ochsner.org
Caitlin Taylor
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nusayba Bagegni
- Recruiting
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307
Site Public Contact, 219-836-6879, CancerResearch@powershealth.org
Maria T. Grosse-Perdekamp
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Nan Chen
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Thomas J. Saphner
- Recruiting
Houston Methodist Cypress Hospital
Cypress, Texas, 77429
Site Public Contact, 346-356-1413, irb@houstonmethodist.org
Kai Sun
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Heather L. McArthur
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Heather L. McArthur
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Heather L. McArthur
- Recruiting
Danbury Hospital
Danbury, Connecticut, 06810
Site Public Contact, 833-223-4732
Wenli Gao
- 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
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Jhansi L. Koduri
- Active, not recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Jhansi L. Koduri
- Recruiting
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
Jane L. Meisel
- 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
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
William J. Gradishar
- Recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
Grady Memorial Hospital
Delaware, Ohio, 43015
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
UCHealth - Cherry Creek
Denver, Colorado, 80206
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Marie E. Wood
- Recruiting
AdventHealth Porter
Denver, Colorado, 80210
Site Public Contact, research.institute@adventhealth.com
Yousuf A. Gaffar
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Mariya Rozenblit
- 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
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- 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
Elie G. Dib
- 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
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Thomas J. Saphner
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Jennifer M. Suga
- Recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
Dublin Methodist Hospital
Dublin, Ohio, 43016
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Alfred P. Vargas
- Recruiting
Northside Hospital - Duluth
Duluth, Georgia, 30096
Site Public Contact, 404-303-3355, Clinical.trials@northside.com
Amelia B. Zelnak
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805
Site Public Contact, 218-249-7825, kdean@slhduluth.com
Homam Alkaied
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Alexandra Thomas
- 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
Elie G. Dib
- Recruiting
The Cancer Institute at Saint Francis Hospital
East Hills, New York, 11548
Site Public Contact, 516-325-7514, Stephanie.Solito@chsli.org
Rajasree Roy
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
Site Public Contact, 315-472-7504
Steven M. Duffy
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Michael Husak
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- 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
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
Elizabeth, New Jersey, 07207
Site Public Contact, 908-994-8000
Mridula A. George
- 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
Stanford Cancer Center Emeryville
Emeryville, California, 94608
Site Public Contact, 650-498-7061, ccto-office@stanford.edu
Melinda L. Telli
- 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
Saint Vincent Hospital
Erie, Pennsylvania, 16544
Site Public Contact, 814-452-5000
Chirag S. Shah
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- 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
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Melissa Yacur
- Recruiting
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Melissa Yacur
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Mariya Rozenblit
- Recruiting
Thomas Hospital
Fairhope, Alabama, 36532
Site Public Contact, 251-435-4584
Prajwol Pathak
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Melissa Yacur
- 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 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
Farmington Health Center
Farmington, Utah, 84025
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Namita Chittoria
- Recruiting
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703
Site Public Contact, 479-872-8100, research@hogonc.com
Joseph T. Beck
- Recruiting
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939
Site Public Contact, 540-332-5960
Kelvin B. Raybon
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
McLeod Regional Medical Center
Florence, South Carolina, 29506
Site Public Contact, 843-777-0770, dorie.sturgill@mcleodhealth.org
Rajesh Bajaj
- Recruiting
Levine Cancer Institute - Rutherford
Forest City, North Carolina, 28043
Site Public Contact, 800-804-9376
Ashley G. Matusz-Fisher
- Recruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Site Public Contact, 515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Shannon B. Keating
- Recruiting
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Janine Harewood
- Recruiting
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
Site Public Contact, 877-784-4673
Melanie Clark
- Active, not recruiting
Tarrant County Hospital District/JPS Health Network
Fort Worth, Texas, 76104
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Heather L. McArthur
- Recruiting
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035
Site Public Contact, 877-338-7425
Sudha Bolla
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Jhansi L. Koduri
- Recruiting
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
Franklin, Wisconsin, 53132
Site Public Contact, AWRI.Inquiry@Ascension.org
Jonathan S. Treisman
- Recruiting
FMH James M Stockman Cancer Institute
Frederick, Maryland, 21702
Site Public Contact, 301-668-7043
Dongyan Liu
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Site Public Contact, 833-574-2273
Jennifer M. Suga
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Active, not recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
- Recruiting
Kaiser Permanente-Gaithersburg Medical Center
Gaithersburg, Maryland, 20879
Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org
James Liu
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
UNC Health Cancer Care Garner
Garner, North Carolina, 27529
- Recruiting
Levine Cancer Institute-Gaston
Gastonia, North Carolina, 28054
Site Public Contact, 800-804-9376
Ashley G. Matusz-Fisher
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
William J. Gradishar
- Recruiting
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440
Site Public Contact, 843-545-5600, broe@tidelandshealth.org
Frank J. Brescia
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Adams Cancer Center
Gettysburg, Pennsylvania, 17325
Site Public Contact, 877-441-7957
Marianne Spengler
- Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Mariya Rozenblit
- Recruiting
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
Site Public Contact, 410-553-8100
Katherine H. Tkaczuk
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
Poornima Saha
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
William J. Gradishar
- Recruiting
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338
Site Public Contact, 623-207-3000
Cynthia A. Lynch
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
- Recruiting
Three Rivers Community Hospital
Grants Pass, Oregon, 97527
Site Public Contact, 541-472-7000
Alison D. Savage
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
William J. Gradishar
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, 11740
Site Public Contact, 516-734-8896
Brittney S. Zimmerman
- Recruiting
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina, 27410
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Site Public Contact, 252-744-1015, eubankss@ecu.edu
Mahvish Muzaffar
Canada14 sites, 14 recruiting
- Recruiting
Cambridge Memorial Hospital
Cambridge, Ontario, N1R 3G2
Site Public Contact, 519-621-2333
Skander Ghedira
- Recruiting
BCCA-Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Site Public Contact, 250-712-3900
Sara K. Taylor
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Site Public Contact, 613-549-6666, cc-clinicaltrials@kgh.kari.net
Brooke E. Wilson
- Recruiting
London Regional Cancer Program
London, Ontario, N6A 4L6
Site Public Contact, 519-685-8600
Hamid Mithoowani
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Site Public Contact, 514-340-8222 ext. 8248
Jennifer Friedmann
- Recruiting
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6
Site Public Contact, 613-761-4395
Sharon McGee
- 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
Muhammad H. Khan
- Recruiting
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Site Public Contact, 506-648-6890
Amy Groom
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Site Public Contact, 306-655-2914
Shahid Ahmed
- Recruiting
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Site Public Contact, 416-480-5000
Katarzyna (Kasia) J. Jerzak
- Recruiting
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca
David W. Cescon
- Recruiting
Centre Hospitalier Regional de Trois-Rivieres
Trois-Rivières, Quebec, G8Z 3R9
Site Public Contact, 819-697-3333 ext. 64399
Anouk Tremblay
- Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Site Public Contact, 888-939-3333
Stephen K. Chia
Puerto Rico4 sites, 4 recruiting
- Recruiting
Doctors Cancer Center
Manati, 00674
Site Public Contact, 787-621-4397
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
About this study
Official title: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy
This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation is as good as receiving pembrolizumab for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and pembrolizumab.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate whether observation results in a non-inferior recurrence-free survival (RFS) compared to adjuvant pembrolizumab in early-stage triple-negative breast cancer (TNBC) patients who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy with pembrolizumab.
II. To compare quality of life (QOL) at approximately 27 weeks as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) Trial Outcome Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To assess the social value of de-escalation of adjuvant breast cancer immunotherapy at approximately 27 weeks and, by modeling, over a lifetime. (Value of Care)
SECONDARY OBJECTIVES:
- To evaluate whether observation compared to adjuvant pembrolizumab impacts the following:
Ia. RFS by stage at presentation and by receipt of prior anthracycline therapy; Ib. Adverse event rate: difference in Grade 3 or higher adverse event rates overall and Grade 3 or higher immune-related adverse events (irAEs) rates; Ic. Overall Survival (OS); Id. Locoregional recurrence (LRR both isolated LRR as first events and LRR events simultaneous with distant metastases [DM]); Ie. RFS, LRR, OS, adverse events, and QOL by age (=< 45, 46-65, and > 65), race, and ethnicity; If. Adverse events related to receipt of radiotherapy. II. To assess the value of de-escalation of breast cancer immunotherapy from the payer perspective at approximately 27 weeks and, by modelling, over a lifetime. (Value of Care) III. To compare patient out-of-pocket costs at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) IV. To compare financial toxicity at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To compare work/productivity impairment at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care)
EXPLORATORY OBJECTIVES:
- To describe trajectories of QOL over time among patients randomized to adjuvant pembrolizumab versus (vs.) observation. (Quality of Life) II. To compare various QOL domains after approximately 27 weeks as assessed by the 5 subscales of the FACT-B Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To compare self-reported symptomatic adverse events at approximately 27 weeks assessed by the patient reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) IV. To describe trajectories of financial toxicity and work/productivity impairment over time from baseline to approximately 27 weeks among patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To develop and assess a measure of value from the patient perspective at approximately 27 weeks. (Value of Care)
OUTLINE: Patients are randomized to 1 of 2 arms after completing neoadjuvant chemotherapy in combination with pembrolizumab, followed by definitive breast surgery.
ARM I (PEMBROLIZUMAB): Patients receive pembrolizumab intravenously (IV) over 25-40 minutes once every 3 weeks (Q3W) or once every 6 weeks (Q6W) for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or magnetic resonance imaging (MRI) during follow-up.
ARM II (OBSERVATION): Patients undergo observation for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI during follow-up.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Being tested
- Pembrolizumab, Patient Observation, Biopsy, Biospecimen Collection, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called Keytruda
Given IV
Patient ObservationOther
Also called Active surveillance, watchful waiting, observation
Undergo observation
BiopsyProcedure or surgery
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Undergo collection of blood
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (pembrolizumab) | Active comparator | Patients receive pembrolizumab IV over 25-40 minutes Q3W or Q6W for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI and during follow-up. Receives: Biological: Pembrolizumab; Procedure: Biopsy; Procedure: Biospecimen Collection; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
| Arm II (observation) | Experimental | Patients undergo observation for 27 weeks. Patients also undergo tumor biopsy and collection of blood throughout the study. Patients also undergo mammography, breast ultrasound or MRI during follow-up. Receives: Other: Patient Observation; Procedure: Biopsy; Procedure: Biospecimen Collection; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
Defined as the time from randomization to first invasive local, regional, or distant recurrence or death due to any cause. RFS will be compared between treatment arms using the hazard ratio (with 90% confidence interval and stratified log-rank test) from a stratified Cox model.
Measured: Up to 10 years.
Secondary outcomes (4)
Incidence of adverse events (AEs)
Adverse events will be determined using the latest version of the Common Terminology Criteria for Adverse Events (CTCAE). The proportions of patients with a grade 3 or higher AE will be compared between the arms using a chi-square test. A similar analysis will be done to compare the grade 3 or higher irAE rates
Measured: Up to 27 weeks after registration
Overall survival
Defined as the time from randomization to death due to any cause. OS will be compared between treatment arms using the hazard ratio (and stratified log-rank test) from a stratified Cox model
Measured: Up to 10 years.
Locoregional recurrence incidence
Defined as the time from randomization to first invasive local or regional recurrence. The cumulative incidence of LRR will be compared between treatment arms using a log-rank test (and estimated using Kaplan-Meier curves).
Measured: Up to 10 years.
Radiation adverse events
Radiation adverse events include pneumonitis, hypothyroidism and dermatitis. Radiation AE event rates will be determined for patients who received radiation. The numerator is the number of patients with the radiation AE and the denominator is the number of patients who received radiation. The analysis of the radiation related adverse event rates will only include patients who received radiation treatment. The radiation AE rates will be compared between the two arms using a chi-square test.
Measured: Up to 27 weeks after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start14 Jun 2023
- Primary completion31 May 2033 (estimated)
- Study completion31 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage II Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,295 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812807
- Sponsor's protocol ID
- A012103
- Other IDs
- NCI-2022-07859
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided