Anatomic Stage II Breast Cancer AJCC v8Phase 3NCT07391774
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
A Phase 3 study testing Anastrozole, Biospecimen Collection and Bone Scan in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIIA Breast Cancer AJCC v8, run by National Cancer Institute (NCI) at 223 sites in 2 countries.
Trial summary
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). 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, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- What is being tested?
- Anastrozole, Biospecimen Collection and Bone Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,978 participants
- Where
- 223 sitesin 2 countries
- Study dates
- 10 Aug 2026to 31 Jul 2029
- 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
- STEP 0: Patient must be ≥ 18 years of age
- STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration
- STEP 0: Patient must be a postmenopausal woman or a man
- NOTE: Menopause can be determined by any of the following:
- Prior bilateral oophorectomy
- Age ≥ 60 years
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- Age < 60 years with amenorrhea for ≥ 12 months and estradiol and follicle stimulating hormone (FSH) levels in the postmenopausal range
- NOTE: FSH and estradiol levels should be repeated as clinically indicated to ensure menopausal status in patients with breast cancer with chemotherapy-induced amenorrhea
- STEP 0: Patient must meet one of the following staging criteria postoperatively according to American Joint Committee on Cancer (AJCC) 8th edition criteria
- pT0-T3 with 3 positive ipsilateral lymph nodes (micro-or macrometastatic disease) and no planned axillary lymph node dissection after definitive surgery in the breast and axilla with curative intent.
- pT0-T3 with N2 or N3
- pT3 with N0-N3
- NOTES:
- Patients with T4 breast cancer are not eligible.
- Positive isolated tumor cells (ITCs) in axillary nodes without micro- or macrometastasis are considered N0 for eligibility purposes.
- ITC does not contribute to nodal count for staging purposes
- STEP 0: Patient must have a primary breast tumor that is estrogen receptor (ER) positive with > 10% ER expression by immunohistochemistry (IHC) as per 2020 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Estrogen Receptor Testing Guideline.
- NOTE: ER 1-10% are reported as ER low positive. These tumors have less endocrine-sensitive disease and are not eligible)
- STEP 0: Patient must have a primary breast tumor that is HER2-negative by current ASCO/CAP guidelines utilizing immunohistochemistry and/or fluorescence in situ hybridization (FISH)
- STEP 0: Patient may have multicentric or multifocal breast cancer if the highest stage tumor meets eligibility criteria outlined above, and the tumor sites are felt to represent a single disease process by local pathology or other sites of disease are also ER-positive (> 10%) and HER2 negative, if such testing is completed. If local pathology feels that multicentric or multifocal disease may represent distinct disease processes repeat disease receptor testing is required other sites of disease must also be also ER-positive (> 10%) and HER2-negative
- STEP 0: For patients who have undergone a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) 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 lobular carcinoma in situ (LCIS) are eligible without additional resection
- STEP 0: For patients who have undergone mastectomy, the margins must be free of residual gross tumor. Patients with microscopic positive margins are eligible if post-mastectomy radiation treatment (RT) of the chest wall will be administered
- STEP 0: Patient must have undergone axillary staging with sentinel lymph node biopsy (SLNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND)
- STEP 0: Patient must have no evidence of locoregional or distant metastatic disease by clinical history and physical exam. Treating physician can consider additional imaging evaluation per National Comprehensive Cancer Network (NCCN) guidelines and/or institutional practice
- STEP 0: Patient must be able to have Oncotype DX testing performed.
- If Oncotype DX testing was previously performed, the results of Recurrence Score (RS) must be available and must meet Step 1 eligibility criteria.
- If Oncotype DX testing was not performed yet, tissue from the core, excisional biopsy or surgical specimen of the tumor lesion must be available and must be shipped to Exact Sciences for determination of the Oncotype DX Recurrence Score (RS) for eligibility and stratification.
- NOTE: Exact Sciences will notify the submitting institution of Recurrence Score results within two (2) weeks of receipt of the tumor specimen. Institutions will receive an email notification of eligibility status once Recurrence Score results are entered into Rave by the submitting institution
- STEP 0: Patient must have had their final cancer surgery for breast cancer (including re-excision of margins) less than 16 weeks prior to Step 0 Pre-Registration.
- NOTE: This excludes additional surgery for reconstructive purposes
- STEP 0: 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
- STEP 0: Patients with synchronous DCIS or LCIS are eligible
- STEP 0: Patient with prior history of ER-negative DCIS diagnosed at least 5 years prior to Step 0 Pre-Registration without evidence of recurrence are eligible
- STEP 0: Patient must not have a prior history of invasive ER-positive breast cancer. Patients with a history of ER-negative breast cancer are eligible if they were diagnosed at least 5 years prior to Step 0 Pre-Registration and have had no evidence of recurrence
- STEP 0: Patients must not have received prior endocrine therapy such as tamoxifen, raloxifene, or aromatase inhibitors for chemoprevention within 5 years prior to Step 0 Pre-Registration with the exception of a short course of endocrine therapy of less than 6 weeks duration prior to Step 0 Pre-Registration.
- NOTE: The Oncotype DX for study eligibility must be performed on specimen obtained prior to initiation of any endocrine therapy
- STEP 0: Patient must not be concurrently using systemic hormone replacement therapy (HRT). If receiving HRT at the time of breast cancer diagnosis, this must be discontinued prior to Step 0 Pre-Registration with appropriate washout
- STEP 0: Absolute neutrophil count (ANC) ≥ 1,500/µL (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Hemoglobin ≥ 9.0 g/dL (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Platelets ≥ 100,000/µL (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Total bilirubin ≤ institutional upper limit of normal (ULN) or < 1.5 x ULN for patients who have a bilirubin elevation in patients with well documented Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × institutional ULN (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/minute/1.73 m^2 (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 Pre-Registration are eligible for this trial
- STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- STEP 0: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- STEP 0: 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 2 or better
- STEP 0: Patient must have a standard 12-lead electrocardiogram (ECG) within 28 days prior to Step 0 Pre-Registration, documenting:
- QT interval using Fridericia's correction (QTcF) < 450 msec.
- Resting heart rate 50-90 beats per minute (determined from the ECG)
- STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- STEP 0: Patient must not have comorbidities considered a safety risk for standard adjuvant chemotherapy, endocrine therapy or CDK4/6 inhibitor as per Investigator's discretion
- STEP 0: Patient must not have a contraindication to adjuvant chemotherapy based on treating physician's discretion
- STEP 0: Patient must not have received prior chemotherapy for this malignancy
- STEP 0: Patient must not have received prior CDK4/6 inhibitor
- STEP 0: Patient must not have a known contraindication to ribociclib per current Food and Drug Administration (FDA) indication
- STEP 0: Patient must not have a known hypersensitivity to any of the excipients of ribociclib and/or endocrine therapy (ET) (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy)
- STEP 0: Males must not expect to father children and males and their partners must be willing to use highly effective methods of contraception while on protocol treatment. Males must not donate sperm while on protocol treatment and for at least 12 weeks following the last dose of protocol treatment.
- Highly effective methods include the following:
- Intrauterine device
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence If the highly effective contraceptive methods are contraindicated or strictly declined by the patient, or in the event of sexual activity of low frequency, a combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods) is also considered an acceptable birth control method. Local regulation/guidelines are to be followed with regard to highly effective birth control method, if more restrictive
- STEP 1: Patient must meet all Step 0 Pre-Registration eligibility criteria at the time of their Step 1 randomization
- STEP 1: Patient must not have had any major surgery or radiotherapy within 14 days prior to Step 1 randomization
- STEP 1: Patient must have a Recurrence Score (RS) of 0-25 from Oncotype DX testing from diagnostic biopsy or surgical specimen as reported by the Exact Sciences assay
Who cannot join
None listed.
Trial locations and contacts
223 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
223 sites in 2 countries
United States219 sites, 219 recruiting
- Recruiting
UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen, Maryland, 21001
Site Public Contact, 443-643-1029, nfadrwoski@umm.edu
Katherine H. Tkaczuk
- 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
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
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- 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
Sutter Auburn Faith Hospital
Auburn, California, 95602
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
IU Health West Hospital
Avon, Indiana, 46123
Site Public Contact, 317-278-5632, iutrials@iu.edu
Tarah J. Ballinger
- 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
Priyanka Mittar
- Recruiting
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Site Public Contact, 443-643-3010
Katherine H. Tkaczuk
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Simran A. Elder
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Site Public Contact, towercancerresearch@toweroncology.com
Yuan Yuan
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
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
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
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220
Site Public Contact, 646-754-4624, david.wallach@nyulangone.org
Nancy Chan
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Hiba Jabbour-Aida
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Ellis G. Levine
- 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
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Sunitha Vemulapalli
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
IU Health North Hospital
Carmel, Indiana, 46032
Site Public Contact, 317-278-5632, iutrials@iu.edu
Tarah J. Ballinger
- 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
- 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
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
Allison M. Zibelli
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Lisa E. Flaum
- Recruiting
Northwestern Medicine Cancer Center Old Irving Park
Chicago, Illinois, 60641
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Lisa E. Flaum
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Hiba Jabbour-Aida
- 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
Elizabeth John
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Elizabeth John
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Nerea Lopetegui-Lia
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Maria T. Grosse-Perdekamp
- 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
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
Hiba Jabbour-Aida
- 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
Lisa E. Flaum
- 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
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Hiba Jabbour-Aida
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Alexandra Thomas
- 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
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601
Site Public Contact, 410-822-1000, Christina.weisenborn@umm.edu
Katherine H. Tkaczuk
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- 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
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
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- 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
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Jhansi L. Koduri
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Lisa E. Flaum
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Lisa E. Flaum
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Lisa E. Flaum
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Jhansi L. Koduri
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Elizabeth John
- Recruiting
HaysMed
Hays, Kansas, 67601
Site Public Contact, 785-623-5774
Ryan Rader
- Recruiting
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Site Public Contact, 717-531-3779, CTO@hmc.psu.edu
Cristina I. Truica
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
Northwestern Medicine Huntley Hospital
Huntley, Illinois, 60142
Site Public Contact, 815-334-5566
Lisa E. Flaum
- Recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Site Public Contact, 317-278-5632, iutrials@iu.edu
Tarah J. Ballinger
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Ritesh Parajuli
- Recruiting
Allegiance Health
Jackson, Michigan, 49201
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Hiba Jabbour-Aida
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org
Elizabeth John
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Ryan Rader
- Recruiting
University Health Truman Medical Center
Kansas City, Missouri, 64108
Site Public Contact, 816-404-4375
Ryan Rader
- Recruiting
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
Site Public Contact, 913-588-3671
Ryan Rader
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Ryan Rader
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Lisa E. Flaum
- Recruiting
The Watson Clinic
Lakeland, Florida, 33805
Site Public Contact, 863-680-7780
Shalini Mulaparthi
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Elie G. Dib
- Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Ryan Rader
- Recruiting
Liberty Hospital
Liberty, Missouri, 64068
Site Public Contact, 913-588-1569
Ryan Rader
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Monmouth Medical Center
Long Branch, New Jersey, 07740
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Coral O. Omene
- Recruiting
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, 24501
Site Public Contact, 434-200-1495, Kevin.Patel@centrahealth.com
Masey M. Ross
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Northwestern Medicine McHenry Hospital
McHenry, Illinois, 60050
Site Public Contact, 815-344-8000
Lisa E. Flaum
- Recruiting
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
William J. Irvin
- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Elizabeth John
- Recruiting
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
William J. Irvin
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Site Public Contact, 212-263-4432, cancertrials@nyulangone.org
Nancy Chan
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Memorial Medical Center
Modesto, California, 95355
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com
Jay W. Carlson
- Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Site Public Contact, research.institute@phci.org
Timothy R. Wassenaar
- Recruiting
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Elizabeth John
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-7356
Coral O. Omene
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Caitlin Taylor
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Mount Sinai Chelsea
New York, New York, 10011
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Anupama Goel
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Site Public Contact, CancerTrials@nyulangone.org
Nancy Chan
- Recruiting
Mount Sinai West
New York, New York, 10019
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Anupama Goel
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Anupama Goel
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Hiba Jabbour-Aida
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Lisa E. Flaum
- Recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Site Public Contact, 262-928-7878
Timothy R. Wassenaar
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Unaiza Zaman
- Recruiting
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu
Ryan Rader
- Recruiting
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Site Public Contact, 402-559-5600
Simran A. Elder
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Simran A. Elder
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Ritesh Parajuli
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Lisa E. Flaum
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Ryan Rader
- Recruiting
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Ryan Rader
- Recruiting
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Elizabeth John
- Recruiting
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
Huntington Memorial Hospital
Pasadena, California, 91105
Site Public Contact, 626-535-2420
Yuan Yuan
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Allison M. Zibelli
- Recruiting
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Allison M. Zibelli
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Women and Infants Hospital
Providence, Rhode Island, 02905
Site Public Contact, 401-274-1122
William M. Sikov
- Recruiting
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607
Site Public Contact, 919-785-4878
Alexandra Thomas
- Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Bon Secours Richmond Community Hospital
Richmond, Virginia, 23223
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
William J. Irvin
- Recruiting
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
William J. Irvin
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Masey M. Ross
- Recruiting
Sutter Roseville Medical Center
Roseville, California, 95661
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
Sutter Medical Center Sacramento
Sacramento, California, 95816
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Site Public Contact, 916-734-3089
Helen K. Chew
- Recruiting
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Site Public Contact, 877-229-4907, coborncancercenter@centracare.com
Donald J. Jurgens
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
Mills Health Center
San Mateo, California, 94401
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Ridley-Tree Cancer Center
Santa Barbara, California, 93105
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Allison M. Zibelli
- Recruiting
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Daniel Almquist
- Recruiting
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Elizabeth John
- Recruiting
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, 06904
Site Public Contact, 203-323-8944
K.M. S. Lo
- Recruiting
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
Site Public Contact, 701-364-6272
Bret E. Friday
- Recruiting
Cedars-Sinai Cancer - Tarzana
Tarzana, California, 91356
Site Public Contact, 818-981-3818
Yuan Yuan
- Recruiting
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
Site Public Contact, 605-312-3320
Daniel Almquist
- Recruiting
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Site Public Contact, 785-295-8000
Ryan Rader
- Recruiting
Upper Valley Medical Center
Troy, Ohio, 45373
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Jhansi L. Koduri
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Maria T. Grosse-Perdekamp
- Recruiting
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589
Site Public Contact, clinicalresearch@sutterhealth.org
Kristie A. Bobolis
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Lisa E. Flaum
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-7632
Timothy R. Wassenaar
- Recruiting
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-5539, Chanda.miller@phci.org
Timothy R. Wassenaar
- Recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Hiba Jabbour-Aida
- Recruiting
Lexington Health
West Columbia, South Carolina, 29169
Site Public Contact, 803-935-8300, research@lexhealth.org
Steven A. Madden
- Recruiting
Good Samaritan University Hospital
West Islip, New York, 11795
Site Public Contact, 516-326-7514
Meytal Fabrikant
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Ryan Rader
- Recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Allison M. Zibelli
- Recruiting
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187
Site Public Contact, 605-312-3320
Daniel Almquist
- Recruiting
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192
Site Public Contact, nhay@hfhs.org
Hiba Jabbour-Aida
- Recruiting
UCI Health - Yorba Linda
Yorba Linda, California, 92886
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Ritesh Parajuli
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
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, ecog.rss@jimmy.harvard.edu
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: A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS Less Than or Equal to 25 (RxFINE-Low)
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether optimal adjuvant endocrine therapy with CDK4/6 inhibitor is non-inferior to adjuvant chemotherapy followed by optimal endocrine therapy with CDK4/6 inhibitor as evaluated by invasive breast cancer-free survival (iBCFS).
SECONDARY OBJECTIVES:
- To compare 5-year invasive disease-free survival (iDFS), distant disease-free survival (DDFS), distant recurrence-free survival (DRFS), recurrence-free interval (RFI), overall survival (OS), and breast cancer-specific survival (BCSS) in patients who receive adjuvant chemotherapy versus patients who do not.
II. To compare the short-term and long-term toxicity profiles of each arm.
EXPLORATORY OBJECTIVE:
- To create a biorepository of tumor tissue and peripheral blood biospecimens for future research.
OUTLINE:
STEP 0: Patients undergo Oncotype DX risk recurrence testing. Patients with an Oncotype DX recurrence score of 0-25 proceed to step 1. Patients with a recurrence score of 26-100 do not continue on the study.
STEP 1: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive their physician's choice of standard of care chemotherapy. Patients then receive their physician's choice of standard of care hormone therapy with letrozole, anastrozole, or exemestane orally (PO) once daily (QD) on days 1-28 of each cycle, as well as ribociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for at least 60 months for hormone therapy and up to 3 years for ribociclib, in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scan, bone scan, or fludeoxyglucose (FDG) positron emission tomography (PET)-CT scan and may optionally undergo blood sample collection throughout the study.
ARM B: Patients receive their physician's choice of standard of care hormone therapy with letrozole, anastrozole, or exemestane PO QD on days 1-28 of each cycle and ribociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for at least 60 months for hormone therapy and up to 3 years for ribociclib, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, bone scan, or FDG PET-CT scan and may optionally undergo blood sample collection throughout the study.
Patients are followed every 3 months for 12 months from randomization, every 6 months for years 1-5 from randomization, then every 12 months for years 5-10 from randomization.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
- Being tested
- Anastrozole, Biospecimen Collection, Bone Scan, Chemotherapy, Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Anastrazole, Arimidex, ICI D1033, ICI-D1033
Given PO
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Bone ScanProcedure or surgery
Also called Bone Scintigraphy
Undergo bone scan
ChemotherapyDrug
Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Receive standard of care chemotherapy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
ExemestaneDrug
Also called Aromasin, FCE-24304
Given PO
LetrozoleDrug
Also called CGS 20267, CGS-20267, CGS20267, Femara
Given PO
Oncotype DX Breast Cancer AssayProcedure or surgery
Also called Oncotype DX
Undergo risk recurrence testing
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo FDG PET scan
Ribociclib SuccinateDrug
Also called Kisqali
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (chemotherapy, hormone therapy, ribociclib) | Active comparator | Patients receive their physician's choice of standard of care chemotherapy. Patients then receive their physician's choice of standard of care hormone therapy with letrozole, anastrozole, or exemestane PO QD on days 1-28 of each cycle, as well as ribociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for at least 60 months for hormone therapy and up to 3 years for ribociclib, in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan, bone scan, or FDG PET-CT scan and may optionally undergo blood sample collection throughout the study. Receives: Drug: Anastrozole; Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Chemotherapy; Procedure: Computed Tomography; Drug: Exemestane; Drug: Letrozole; Procedure: Oncotype DX Breast Cancer Assay; Procedure: Positron Emission Tomography; Drug: Ribociclib Succinate |
| Arm B (hormone therapy, ribociclib) | Experimental | Patients receive their physician's choice of standard of care hormone therapy with letrozole, anastrozole, or exemestane PO QD on days 1-28 of each cycle and ribociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for at least 60 months for hormone therapy and up to 3 years for ribociclib, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, bone scan, or FDG PET-CT scan and may optionally undergo blood sample collection throughout the study. Receives: Drug: Anastrozole; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Exemestane; Drug: Letrozole; Procedure: Oncotype DX Breast Cancer Assay; Procedure: Positron Emission Tomography; Drug: Ribociclib Succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive breast cancer-free survival (iBCFS)
Invasive disease defined as the first occurrence of one of the following events: local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, or contralateral invasive breast cancer. The distribution of iBCFS will be estimated using the Kaplan-Meier method. The hazard ratio will be estimated using Cox proportional hazard model. The primary analysis will compare treatment groups defined by the randomized treatment assignment (intent-to-treat analysis). A secondary analysis will be performed comparing groups defined by treatment received (per protocol analysis).
Measured: From randomization to invasive disease or death, up to 10 years
Secondary outcomes (8)
Invasive disease free survival
Occurrence of invasive disease defined as the first occurrence of one of the following events: local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, or second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin). Will be defined according to Standardized Definitions for Efficacy End Points (in Adjuvant Breast Cancer Trials) (STEEP) criteria and analyzed similarly as iBCFS.
Measured: From randomization to the first occurrence of invasive disease or death, up to 10 years
Distant disease free survival
Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Measured: Up to 10 years
Distant recurrence free survival
Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Measured: Up to 10 years
Recurrence-free interval
Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Measured: Up to 10 years
Overall survival
Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Measured: From randomization to death, up to 10 years
Breast cancer specific survival
Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Measured: Up to 10 years
Incidence of short term adverse events
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Will be summarized by treatment group and the NCI CTCAE worst grade.
Measured: Up to 10 years
Incidence of long term adverse events
Adverse events will be graded using the NCI CTCAE. Will be summarized by treatment group and the NCI CTCAE worst grade.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Aug 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (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 National Cancer Institute (NCI)The 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
- 1,978 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nancy Chan, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391774
- Sponsor's protocol ID
- NCI-2026-00634
- Other IDs
- NCI-2026-00634, EA1242, EA1242, U10CA180820
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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.