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Anatomic Stage IIIC Breast Cancer AJCC V8 / Anatomic Stage Ii Breast Cancer AJCC V8 / Anatomic Stage IIIA Breast Cancer AJCC V8 · Phase 3 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an active Phase 3 randomized trial comparing hormone therapy with ribociclib alone versus chemotherapy followed by hormone therapy with ribociclib in patients with high anatomic stage, hormone receptor-positive, HER2-negative breast cancer with low recurrence risk. No efficacy or safety results are currently available in this registry record; the trial is still recruiting and outcome data are not yet posted.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breas…; age from 18 Years. Intervention: Arm B (hormone therapy, ribociclib). Compared with: Arm A (chemotherapy, hormone therapy, ribociclib) — Active Comparator. n = 1,978. 132 sites: United States, Puerto Rico.
This is an active Phase 3 randomized trial comparing hormone therapy with ribociclib alone versus chemotherapy followed by hormone therapy with ribociclib in patients with high anatomic stage, hormone receptor-positive, HER2-negative breast cancer with low recurrence risk. No efficacy or safety results are currently available in this registry record; the trial is still recruiting and outcome data are not yet posted.
This is a registry record only; no efficacy or safety results are reported.
Once results are available, this trial will inform whether chemotherapy can be omitted in selected high-anatomic-stage, hormone receptor-positive breast cancer patients with low recurrence risk, potentially sparing toxicity. Clinicians should not change practice based on this registry entry alone, as no efficacy data have been reported.
This is an active Phase 3 trial registration with no results posted; the study design is sound but outcome data are not yet available to assess efficacy or safety.
As stated by the source record.
Quoted from the source exactly as published.
Once results are available, this trial will inform whether chemotherapy can be omitted in selected high-anatomic-stage, hormone receptor-positive breast cancer patients with low recurrence risk, potentially sparing toxicity. Clinicians should not change practice based on this registry entry alone, as no efficacy data have been reported.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07391774). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1978 participants (ESTIMATED). 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. Interventions: 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. Primary outcome measures: Invasive breast cancer-free survival (iBCFS) , From randomization to invasive disease or death, up to 10 years. Brief 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). 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.