Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1) Pathologic Response
研究概览
简要总结
This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.
详细描述
Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH preferred; HER2 0 or 1+ by IHC acceptable)
- •Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.)
- •Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam acceptable.)
- •Absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3
- •Normal myocardial left ventricular function
- •Serum creatinine < 2.0 mg/dl
- •Total bilirubin and AST < 3X upper limits normal
排除标准
- •Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a second breast primary, patient eligible for this protocol)
- •Another active cancer present
- •Medical contraindications to chemotherapy or surgery
- •First trimester pregnancy
- •Breast feeding
研究组 & 干预措施
Neoadjuvant metronomic AC followed by weekly TC
Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery
干预措施: Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin (Drug)
Neoadjuvant metronomic AC followed by weekly TC
Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery
干预措施: Definitive Surgery (Procedure)
Neoadjuvant metronomic AC followed by weekly TC
Neoadjuvant chemotherapy with metronomic AC followed by weekly TC then surgery
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
1) Pathologic Response
时间窗: Upon completion therapy after surgery
Pathologic measurement post-surgery viable primary tumor mass
次要结局
未报告次要终点