A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study
试验速览
- 阶段
- 3 期
- 入组人数
- 587
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.
详细描述
In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals.
In POST Neo-adjuvant period
Randomization:
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of breast cancer
- •Female patients
- •Histologically confirmed invasive breast cancer
- •Primary tumor greater than 2cm diameter, measured by mammography and sonography
- •ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER <1%, PR<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+)
- •No evidence of metastasis (M0)
- •No prior hormonal, chemotherapy or radiotherapy is allowed.
- •No breast operation other than biopsy to make diagnosis is allowed.
- •Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
- •Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
- •Adequate renal function: Serum creatinine 1.5 mg/dl
- •Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
- •Written informed consent
- •Normal mental function to understand and sign the consent
- •Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment.
- •LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment
排除标准
- •Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
- •Patients who underwent surgery for breast cancer
- •Patients with a history of uncompensated congestive heart failure
- •Patients with inflammatory breast cancer (T4d)
- •Patients without primary tumor (T0)
- •Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
- •Known hypersensitivity to any of the study drugs
研究组 & 干预措施
carboplatin chemotherapy
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
干预措施: carboplatin (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: up to 3 years
To compare DFS between carboplatin and observation within non-pCR (complete remission) patients
次要结局
- overall survival(up to 5years)
- pCR rate(up to 3 years)
- The percentage of patients who receive breast conserving surgery.(up to 3years)
- Number of adverse events(up to 3years)
研究者
Byeong Woo Park
Principal Investigator
Severance Hospital