JPRN-jRCT2080222543已完成3 期
Multicenter, randomized, double-blind, placebo-controlled, Phase 3 trial of fulvestrant (Faslodex) with or without PD-0332991 (palbociclib) +/- goserelin in women with hormone receptor-positive, HER2-negative metastatic breast cancer whose disease progressed after prior endocrine therapy
Pfizer R&D Japan G.K.0 个研究点目标入组 521 人开始时间: 2014年6月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 521
研究概览
简要总结
The addition of palbociclib to fulvestrant resulted in a statistically significant, and clinically meaningful improvement in PFS as compared with placebo plus fulvestrant. The results across response-based analyses, including supportive PFS analyses, OR, DR, and CBR, are consistent and support the robustness of the primary PFS analysis at the time of the data cutoff. The magnitude of treatment effect of the palbociclib combination observed in PFS continued and was maintained for OS at the later cutoff.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •Inclusion Criteria:
- •*Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
- •*Confirmed diagnosis of HR+/HER2- breast cancer
- •*Any menopausal status
- •*Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
- •*On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex) at time of randomization.
- •*Measurable disease defined by RECIST version 1.1, or bone-only disease
- •*Eastern Cooperative Oncology Group (ECOG) PS 0-1
- •*Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
- •*Patient must agree to provide tumor tissue from metastatic tissue at baseline
排除标准
- •Exclusion Criteria:
- •*Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
- •*Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
- •*Major surgery or any anti-cancer therapy within 2 weeks of randomization
- •*Prior stem cell or bone marrow transplantation
- •*Use of potent CYP3A4 inhibitors or inducers
研究者
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