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SELECT: A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-Positive, HER2- Negative Breast Cancer With a Combination Regimen of Ribociclib and Optimized Endocrine Therapy
This is a Phase II Trial to assess the impact of omitting adjuvant chemotherapy based on patient's selection on treatment persistence of CDK4/6 inhibitor, ribociclib (Kisqali), in a well-defined subgroup of patients with resected estrogen receptor (ER)-positive, HER2-negative, lymph node-positive breast cancer, but whose tumor profiling indicates a less aggressive biological nature (OncotypeDx 21-gene recurrence score RS 0-25).
Details
| Lead sponsor | Yale University |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 140 |
| Start date | 2025-07-09 |
| Completion | 2030-09 |
Conditions
- HER2 Negative Breast Cancer
Interventions
- Ribociclib 400mg
- Letrozole 2.5mg
- Anastrazole 1mg
- Goserelin 3.6 MG
- Adjuvant chemotherapy
Primary outcomes
- Discontinuation rate of ribociclib in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer — Within one year of treatment
Discontinuation rate of ribociclib in participants with resected moderate to high-anatomical risk (men or premenopausal women T1-3N1-2, and postmenopausal women T3N1 or T1-3N2), low-genomic risk (RS≤ 25), ER-positive, HER2-negative breast cancer who choose to forgo or include adjuvant chemotherapy in their treatment regimen. One-year treatment discontinuation is defined as treatment discontinuation within one year for any reason (e.g., adverse events, disease recurrence, patient/investigator decision, lost to follow up, etc).
Countries
United States