A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 97
- 主要终点
- Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
研究概览
简要总结
This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or metastatic breast cancer.
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
- Single (Participant)
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
- •Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease
- •Human epidermal growth factor receptor 2 (HER2)-negative and hormone receptor (HR) (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematologic and end organ function
- •Women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer
排除标准
- •Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
- •Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor for advanced or metastatic breast cancer
- •History of intolerance to a taxane-containing therapy
- •History of clinically significant cardiac or pulmonary dysfunction
- •History of malabsorption syndrome or other condition that would interfere with enteral absorption
- •Clinically significant history of liver disease
- •Active autoimmune disease or active inflammatory disease
- •Immunocompromised status due to current known active infection with human immunodeficiency virus (HIV) or due to the use of immunosuppressive therapies for other conditions
- •Need for current chronic corticosteroid therapy
- •Pregnant, lactating, or breastfeeding women
- •Current severe, uncontrolled systemic disease
- •Known untreated or active central nervous system (CNS) metastases
研究组 & 干预措施
A: Paclitaxel, GDC-0941
Participants will receive GDC-091 260 milligrams (mg) orally in repeated rounds of once daily (QD) dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 will not be administered (5/7-day schedule). This 5/7-day schedule will be repeated weekly in each 28-day cycle until disease progression or intolerable toxicity. Participants will receive 90 milligrams per square meter (mg/m^2) intravenously (IV) weekly for 3 out of 4 weeks in every 28-day cycle.
干预措施: GDC-0941 (Drug)
A: Paclitaxel, GDC-0941
Participants will receive GDC-091 260 milligrams (mg) orally in repeated rounds of once daily (QD) dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 will not be administered (5/7-day schedule). This 5/7-day schedule will be repeated weekly in each 28-day cycle until disease progression or intolerable toxicity. Participants will receive 90 milligrams per square meter (mg/m^2) intravenously (IV) weekly for 3 out of 4 weeks in every 28-day cycle.
干预措施: Paclitaxel (Drug)
B: Paclitaxel, Placebo
Participants will receive placebo matching to GDC-0941 on the 5/7-day schedule along with 90 mg/m^2 IV weekly for 3 out of 4 weeks in every 28-day cycle.
干预措施: Placebo (Drug)
B: Paclitaxel, Placebo
Participants will receive placebo matching to GDC-0941 on the 5/7-day schedule along with 90 mg/m^2 IV weekly for 3 out of 4 weeks in every 28-day cycle.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
时间窗: From the time of randomization until disease progression or death from any cause (up to approximately 3 years)
次要结局
- Percentage of Participants With Adverse Events(From randomization up to approximately 3 years)
- Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1(From first observation of an objective tumor response until disease progression (up to approximately 3 years))
- Population PK for Paclitaxel(Day 1 of Cycle 1 (cycle length=28 days))
- Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1(From first observation of an objective tumor response until disease progression (up to approximately 3 years))
- Percentage of Participants Acheiving Clinical Benefit (Partial Response, Complete Response or Stable Disease Lasting for at Least 6 Months) Assessed as per Modified RECIST v1.1(From randomization until disease progression (up to approximately 3 years))
- Population Pharmacokinetics (PK) for GDC-0941(Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days))