NCT01120561No Longer Available不适用
An Expanded Access, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.
研究设计
- 研究类型
- Expanded Access
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
- •Histologically or cytologically documented breast cancer
- •Locally advanced or metastatic breast cancer
- •HER2-positive breast cancer documented as FISH-positive, IHC 3 + or CISH-positive by local laboratory assessment
- •Histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer previously treated with multimodality therapy or metastatic breast cancer
- •Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both: a taxane, alone or in combination with another agent, and Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting
- •Documented progression of incurable unresectable, locally advanced, or metastatic breast cancer during their most recent treatment regimen
- •Progression must occur during or after most recent treatment for locally advanced/metastatic breast cancer or within 6 months after completing adjuvant therapy
- •Adequate hematologic and end organ function
- •Agreement to use an effective form of birth control throughout the study
- •Life expectancy ≥ 90 days as assessed by the investigator
排除标准
- •Less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy
- •Prior T-DM1 therapy
- •History of exposure to cumulative doses of select anthracyclines
- •History of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued
- •Brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment
- •Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, at the time of the first study treatment
- •History of clinically significant cardiac dysfunction
- •Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
- •Current severe, uncontrolled systemic disease
- •Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment
- •Pregnancy or lactation
- •NOTE: The site selection process has been completed. Patients can enroll at participating sites.
研究者
研究点 (1)
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