drugset / Trial / NCT06953882
Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
Phase 2
Recruiting
140 enrolled
Yale University
Breast Cancer Research Foundation · collabNovartis · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase II, two-arm, single center, patient preference study designed to evaluate the impact of omitting adjuvant chemotherapy in moderate to high-anatomical risk, low-genomic risk (men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30, or T1-3N1 and RS 26-30, or T1-3N2 and RS ≤ 25),
Timeline
- Start
- 2025-07-09
- Primary completion
- 2030-09
- Completion
- 2030-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anastrozole | Other / unclassified | 1 mg | Oral |
| Subject | Goserelin | Other / unclassified | 3.6 mg | Other |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Subject | Ribociclib | Small molecule | 400 mg | Oral |