Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
Phase 2
Completed
NCT03671330
| Condition | Breast Cancer |
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| Phase | Phase 2 |
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| Sponsor | Novartis Pharmaceuticals |
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| Status | Completed |
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| Enrollment | 327 participants |
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| Interventions | Ribociclib Placebo, Ribociclib, NSAI: Letrozole or Anastrazole, Goserelin |
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| Start date | Aug 29, 2018 |
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| Completion date | Apr 25, 2022 |
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| Results posted | Jul 8, 2026 |
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Summary
This was a randomized, double-blind, placebo-controlled study conducted in Chinese women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, plus an open-label, single-arm pharmacokinetic (PK) subset in postmenopausal Chinese women with HR+, HER2- advanced breast cancer.
Pre and Postmenopausal Cohorts: Progressive Free Survival (PFS) Based on Local Assessment by RECIST 1.1 Guideline
After approximately 100 progression-free survival (PFS) events had been observed in each cohort, using data collected up to the analysis cut-off date of 25-Apr-2022, an average of 43 months. · Months
| Premenopausal Cohort - Ribociclib | 27.6 Months |
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| Premenopausal Cohort - Placebo | 14.7 Months |
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| Postmenopausal Cohort - Ribociclib | NA Months |
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| Postmenopausal Cohort - Placebo | 18.5 Months |
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| Hazard Ratio (HR) | 0.672 (95% CI 0.448–1.009) |
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