NCT01815242已完成2 期
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
West German Study Group1 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine
研究概览
简要总结
The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Known hypersensitivity reaction to the compounds or incorporated substances
- •Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
- •Non-operable breast cancer including inflammatory breast cancer
- •Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- •Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry
- •Male breast cancer
- •Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
- •Breast feeding woman
- •Sequential breast cancer
- •Reasons indicating risk of poor compliance
- •Patients not able to consent
- •Additional Exclusion Criteria for patients receiving chemotherapy:
- •Known polyneuropathy ≥ grade 2
- •Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease
- •Uncompensated cardiac function
- •Inadequate organ function including:
- •Leucocytes < 3.5 x 10^9/l
- •Platelets < 100 x 10^9/l
- •Bilirubin above normal limits
- •Alkaline phosphatase > 5 x UNL
- •ASAT and/or ALAT associated with AP > 2.5 x UNL
研究组 & 干预措施
Arm A
Experimental
nab-Paclitaxel + gemcitabine
干预措施: nab-Paclitaxel (Drug)
Arm A
Experimental
nab-Paclitaxel + gemcitabine
干预措施: Gemcitabine (Drug)
Arm B
Experimental
nab-Paclitaxel + carboplatin
干预措施: nab-Paclitaxel (Drug)
Arm B
Experimental
nab-Paclitaxel + carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine
时间窗: After 12 weeks of therapy
pCR will be measured after 12 weeks of randomized treatment.
Comparison: pCR in responders vs. non-responders
时间窗: After 12 weeks of therapy
pCR will be measured after 12 weeks of randomized treatment.
次要结局
未报告次要终点
研究者
研究点 (1)
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