Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib ± Goserelin in Women With Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 23
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years of age or older with histologically or cytologically proven locally advanced or metastatic breast cancer, not amenable to resection or radiation therapy with curative intent
- •Documented diagnosis of HR+/HER2- breast cancer
- •Any menopausal status
- •Previously untreated with any endocrine therapy for their HR+/HER2- advanced breast cancer; or progressed while on or within 3 month from prior endocrine therapy other than tamoxifen for advanced breast cancer. If patients have adjuvant endocrine therapy, they must satisfy as follows: progressed 12 months or more since prior adjuvant endocrine therapy with tamoxifen; or progressed during or after adjuvant endocrine therapy with an aromatase inhibitor.
- •Measurable disease or non-measurable disease as defined by RECIST ver.1.1
- •Eastern Cooperative Oncology Group (ECOG) PS 0-1
- •Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
排除标准
- •Prior treatment with any CDK inhibitor, tamoxifen, everolimus, or agent that inhibits the PI3K-mTOR pathway
- •Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
- •Use of strong or moderate CYP3A4 and/or CYP2D6 inhibitors or inducers
- •Major surgery or any anti-cancer therapy within 2 weeks of randomization
- •Prior stem cell or bone marrow transplantation
研究组 & 干预措施
Palbociclib + Tamoxifen ± Goserelin
Palbociclib 125 mg/day, orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
干预措施: Palbociclib (Drug)
Palbociclib + Tamoxifen ± Goserelin
Palbociclib 125 mg/day, orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
干预措施: Tamoxifen (Drug)
Palbociclib + Tamoxifen ± Goserelin
Palbociclib 125 mg/day, orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
干预措施: Goserelin (Drug)
Placebo + Tamoxifen ± Goserelin
Placebo orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
干预措施: Placebo (Drug)
Placebo + Tamoxifen ± Goserelin
Placebo orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
干预措施: Tamoxifen (Drug)
Placebo + Tamoxifen ± Goserelin
Placebo orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
干预措施: Goserelin (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Baseline up to 3.5 years
The time from the date of randomization to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first.
次要结局
- Clinical Benefit Response (CBR)(Baseline up to 3.5 years)
- Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores(Baseline up to 3.5 years)
- Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen(Cycle 2/Day 15 and Cycle 3/Day 15)
- Duration of Response (DR)(Baseline up to 3.5 years)
- Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores(Baseline up to 3.5 years)
- Overall Survival (OS)(From the randomization of the last patient up to 3 years)
- Objective Response (OR)(Baseline up to 3.5 years)
- Survival Probabilities at 1 year, 2 year, and 3 year(From the randomization of the last patient up to 3 years)
- Trough plasma concentrations of palbociclib(Cycle 1/Day 15 and Cycle 2/Day 15)
- Treatment-Emergent Adverse Events(From the first dose of the investigational product until 28 days after the last dose of study drugs)