Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.
研究概览
简要总结
Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Triple Negative Breast Cancer;
- •Stage II or III;
- •Performance Status ECOG <2 or Karnofsky >50%;
- •Hematologic (minimal values):
- •Absolute neutrophil count > 1,500/mm3 Hemoglobin > 10.0 g/dl Platelet count > 100,000/mm3
排除标准
- •Stage I or IV;
- •other malignancies.
研究组 & 干预措施
A- BRCA Mutation
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
干预措施: Doxorubicin (Drug)
A- BRCA Mutation
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
干预措施: Carboplatin (Drug)
A- BRCA Mutation
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
干预措施: Paclitaxel (Drug)
A- BRCA Mutation
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
干预措施: Cyclophosphamide (Drug)
B- BRCA Mutation
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks.
干预措施: Doxorubicin (Drug)
B- BRCA Mutation
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks.
干预措施: Paclitaxel (Drug)
B- BRCA Mutation
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks.
干预措施: Cyclophosphamide (Drug)
C- BRCA wild-type
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
干预措施: Doxorubicin (Drug)
C- BRCA wild-type
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
干预措施: Carboplatin (Drug)
C- BRCA wild-type
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
干预措施: Paclitaxel (Drug)
C- BRCA wild-type
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
干预措施: Cyclophosphamide (Drug)
D- BRCA wild-type
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks.
干预措施: Doxorubicin (Drug)
D- BRCA wild-type
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks.
干预措施: Paclitaxel (Drug)
D- BRCA wild-type
- Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by:
- Paclitaxel 80 mg/m2 once a week, for 12 weeks.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.
时间窗: within the first 21 days after surgery
次要结局
- Disease free survival (DFS)(within the first 60 month after surgery)
- Overall survival (OS)(within the first 60 month after surgery)
研究者
Cristiano de Padua
Principal Investigator
Barretos Cancer Hospital