A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- pathologic complete response
研究概览
简要总结
This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •invasive breast cancer
- •stage I-IIIA disease
- •ER, PR, Her2/neu-negative status
- •no prior treatment for breast cancer
- •age 18 years of greater
- •normal renal, liver function
- •normal hematologic status
- •ECOG Performance status 0, 1
- •Evaluation by a surgeon to determine breast conservation eligibility
- •Women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Metastatic breast cancer
- •Inoperable breast cancer, including Stage IIIB and IIIC
- •Tumor size less than 1 centimeter
- •Prior surgery, systemic therapy, or radiotherapy for the current cancer
- •Hormone receptor-positive breast cancer
- •Her2/neu-positive breast cancer
- •Any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
- •Pregnant or nursing women
- •Receipt of any investigational agents within 30 days prior to commencing study treatment
研究组 & 干预措施
1
standard chemotherapy plus BSI-201
干预措施: gemcitabine plus carboplatin plus BSI-201 (Drug)
结局指标
主要结局
pathologic complete response
时间窗: 4 months
次要结局
未报告次要终点