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

Recruiting now · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07391774

Run by

National Cancer Institute (NCI)

People needed

1978

Starts

2027-02-14

Expected to finish

2029-07-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

Where it is running

• Sutter Auburn Faith Hospital — Auburn, California, United States (enrolling)
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States (enrolling)
• Tower Cancer Research Foundation — Beverly Hills, California, United States (enrolling)
• Palo Alto Medical Foundation Health Care — Palo Alto, California, United States (enrolling)
• Sutter Roseville Medical Center — Roseville, California, United States (enrolling)
• Sutter Medical Center Sacramento — Sacramento, California, United States (enrolling)
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States (enrolling)
• Mills Health Center — San Mateo, California, United States (enrolling)
• Ridley-Tree Cancer Center — Santa Barbara, California, United States (enrolling)
• Cedars-Sinai Cancer - Tarzana — Tarzana, California, United States (enrolling)
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States (enrolling)
• Stamford Hospital/Bennett Cancer Center — Stamford, Connecticut, United States (enrolling)
• Beebe South Coastal Health Campus — Millville, Delaware, United States (enrolling)
• Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (enrolling)
• Beebe Health Campus — Rehoboth Beach, Delaware, United States (enrolling)
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States (enrolling)
• Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States (enrolling)
• Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States (enrolling)
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States (enrolling)
• Illinois CancerCare-Canton — Canton, Illinois, United States (enrolling)
• SIH Cancer Institute — Carterville, Illinois, United States (enrolling)
• Illinois CancerCare-Carthage — Carthage, Illinois, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

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