drugset / Trial / NCT05827081
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).
Timeline
- Start
- 2024-02-28
- Primary completion
- 2029-09-07
- Completion
- 2030-09-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribociclib | Small molecule | 400 mg | Oral |
| Background | Anastrozole | Other / unclassified | 1 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | — |
| Background | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Background | Goserelin | Other / unclassified | 10.8 mg | Subcutaneous |
| Background | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Background | Leuprolide | Other / unclassified | 3.75 mg | Subcutaneous |
| Background | Leuprolide | Other / unclassified | 11.25 mg | Subcutaneous |