NCT00149214已完成2 期
A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Number of Participants With a Pathological Complete Response
研究概览
简要总结
An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-
- •Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).
- •Adequate organ function (bone marrow, hepatic, renal, cardiac).
排除标准
- •Prior anthracyclines as part of prior anticancer therapy.
- •Concurrent antitumor therapy.
- •Second primary malignancy.
- •Serious concomitant systemic disorder.
- •Pre-existing sensorial or motor neuropathy
研究组 & 干预措施
A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
Experimental
干预措施: pemetrexed (Drug)
A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
Experimental
干预措施: doxorubicin (Drug)
A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
Experimental
干预措施: docetaxel (Drug)
B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Active Comparator
干预措施: cyclophosphamide (Drug)
B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Active Comparator
干预措施: doxorubicin (Drug)
B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Active Comparator
干预措施: docetaxel (Drug)
结局指标
主要结局
Number of Participants With a Pathological Complete Response
时间窗: surgery after eight 21-day cycles of chemotherapy
pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
次要结局
- Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy(Cycles 1-4 (21-day cycles))
- Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy(Cycles 5-8 (21-day cycles))
- Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery(surgery after eight 21-day cycles of chemotherapy)
- Disease-free Survival(baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization))
研究者
研究点 (1)
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