Phase I/II Study of Bendamustine and Erlotinib for Metastatic or Locally Advanced Triple Negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or stage IV breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the phase II dose and assess the toxicity of bendamustine hydrochloride and erlotinib hydrochloride in patients with triple-receptor (estrogen receptor, progesterone receptor, and HER-2)-negative, stage IIIB, IIIC, or IV breast cancer. (Phase I)
- To determine the efficacy of this regimen in these patients. (Phase II)
Secondary (Correlative)
- To assess the correlation between tumor EGFR expression and EGFR gene amplification and treatment efficacy and toxicity.
- To assess for differences in treatment efficacy between basal-like and non-basal-like cancers.
- To assess for differences in treatment efficacy between tumors with and without expression of DNA damage-response (DDR) checkpoint proteins.
- To assess for differences in the activation state of DDR checkpoint proteins based on breast cancer subtype.
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bendamustine and Erlotinib
Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.
干预措施: bendamustine (Drug)
Bendamustine and Erlotinib
Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.
干预措施: erlotinib (Drug)
Bendamustine and Erlotinib
Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.
干预措施: Maintenance erlotinib (Drug)
结局指标
主要结局
Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)
时间窗: Up to two years
28 day cycle included intravenous bendamustine on days 1 and 2.
Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)
时间窗: Up to two years
28 day cycle included intravenous erlotinib on days 15-21.
Dose-limiting Toxicity (Phase I)
时间窗: Up to two years
Progression-free Survival at 6 Months and 12 Months (Phase II)
时间窗: Up to two years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Objective Response Rate (ORR)(Up to two years)
- Clinical Benefit Rate (CBR)(Up to two years)
- Duration of Response (DR)(Up to two years)
- Overall Survival (OS)(from time of study enrollment until death, for up to 2 years)
- Relationship of EGFR Expression or Amplification, Basal-like Tumors, and DNA Damage-repair Checkpoint Activation With ORR, CBR, DR, and OS(up to two years)