Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
2期
已完成
NCT03671330
| 适应症 | Breast Cancer |
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| 分期 | 2期 |
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| 申办方 | Novartis Pharmaceuticals |
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| 状态 | 已完成 |
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| 受试者人数 | 327 人 |
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| 干预（药物） | Ribociclib Placebo, Ribociclib, NSAI: Letrozole or Anastrazole, Goserelin |
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| 开始日期 | 2018年8月29日 |
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| 完成日期 | 2022年4月25日 |
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| 结果公布日 | 2026年7月8日 |
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摘要
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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