NCT00517361终止2 期
A Phase II Study of Carboplatin and Bevacizumab (Avastin) Combination Therapy for ER Negative, PR Negative, and HER2/Neu Negative Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.
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
- •Patients must have pathologically confirmed ER, PR and HER2/neu negative (FISH ratio of <2.0 or IHC <1+) metastatic breast cancer. Locally advanced or recurrent disease is also eligible.
- •Patients must have measurable disease
- •Patients must not have received prior chemotherapy for metastatic breast cancer (not including adjuvant therapy). Patients should be > 4 weeks from their most recent chemotherapy or radiation therapy treatment.
- •Age >18 years
- •ECOG performance status <1 (Karnofsky >80%).
- •Patients must have normal organ and marrow function as defined below:
- •absolute neutrophil count >1,500/uL
- •platelets >100,000/uL
- •total bilirubin within normal institutional limits
- •AST(SGOT)/ALT(SGPT) <2.5X institutional upper limit of normal
- •creatinine within normal institutional limits OR creatinine clearance>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •PT INR < 1.5 (Unless patient is on anticoagulation)
- •urine protein <1+
- •Tissue from the primary tumor must be available for correlative studies
- •Women of child-bearing potential must agree to use adequate contraception
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have had prior therapy with platinum agents or a VEGF inhibitor are not eligible.
- •Patients may not be receiving any other investigational agents.
- •Patients with known brain metastases will be excluded
- •Patients may have had prior radiation therapy, provided the patient has measurable disease and there has been clear progression since the completion of radiation therapy. Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to therapy administered more than 4 weeks earlier will be excluded.
- •Patients with significant cardiac dysfunction will be excluded
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study, breastfeeding should be discontinued.
- •HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin or the other agents administered during the study.
- •Patients with evidence of bleeding diathesis or coagulopathy.
- •Patients with inadequately controlled hypertension will be excluded
- •Patients who have had a stroke or TIA within 6 months of registration will be excluded.
- •Patients with a history of hypertensive crisis or hypertensive encephalopathy will be excluded.
- •Patients with a history of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months of registration.
- •Patient with history of serious non-healing wound, ulcer or bone fracture.
- •Patients with major surgery, open biopsy, or significant traumatic injury within 28 days of registration or anticipated need for surgery during course of study treatment.
- •Patients with a history core biopsy or other minor surgery, excluding venous access device (VAD) placement, within 7 days of registration.
- •Patients with active second malignancy.
- •Known hypersensitivity to any component of bevacizumab (Avastin®).
- •Peripheral neuropathy > Grade 1.
研究组 & 干预措施
Carboplatin + Avastin
Experimental
干预措施: carboplatin (Drug)
Carboplatin + Avastin
Experimental
干预措施: bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Up to 5 years
Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
次要结局
- Correlation of Response to BRCA1 Methylation Status(Up to 5 years)
- Response Rate(Up to 5 years)
- Duration of Response(Up to 5 years)
研究者
研究点 (2)
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