An Open Label Study to Assess the Effect of a Combination of Avastin and Docetaxel and Sequential Chemotherapy on Pathological Response in Patients With Primary Operable HER2 Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Percentage of Participants With Pathological Complete Response (pCR)
研究概览
简要总结
This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, >=18 years of age;
- •primary HER2-negative operable breast cancer;
- •tumor >2cm in size;
- •ECOG performance status 0-1.
排除标准
- •previous treatment for breast cancer;
- •metastatic disease;
- •current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) or full-dose anticoagulants for therapeutic purposes;
- •clinically significant cardiovascular disease.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: Docetaxel (Drug)
1
干预措施: Standard chemotherapy (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response (pCR)
时间窗: After Week 24 (surgery)
The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA). It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
次要结局
- Percentage of Participants With pCR by VEGFR Protein Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by RKISS1 Gene Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Proliferation of Ki67(After Week 24 (surgery))
- Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification(After Week 24 (surgery))
- Percentage of Participants With Objective Clinical Response(Within 28 days of enrollment, Weeks 12 and 24)
- Percentage of Participants With pCR by KISS1 Protein Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Angiotension Protein Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression(After Week 24 (surgery))
- Percentage of Participants With Breast-Conserving Surgery(Week 24)
- Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification(After Week 24 (surgery))
- Percentage of Participants With pCR by VEGFR Gene Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by HIF Gene Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by ENOS Gene Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression(After Week 24 (surgery))
- Percentage of Participants With pCR by KISS1 Gene Expression(After Week 24 (surgery))