Comparing TP (Docetaxel + Cisplatin) and TAC (Docetaxel + Doxorubicin + Cyclophosphamide) in Neoadjuvant Therapy for Operable Triple Negative Breast Cancer, A Multicenter, Randomized, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- The pathological complete remission rate (pCR rate)
研究概览
简要总结
Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.
详细描述
In this study, TNBC patients were randomly divided into experimental group and control group, the ratio of experimental group to control group was 1:1. The experimental group received 6 cycles of neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1, 2, 3), 21 days as a cycle. The control group was treated with TAC (docetaxel 75mg / M2 + adriamycin 50mg / M2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. To compare the efficacy and safety of 6*TP (docetaxel + cisplatin) regimen and traditional 6*TAC (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC.
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
- •Clinical T2-T4c, or T1c with axillary LN+.
- •triple negative and invasive breast cancer confirmed by histopathology:
- •Triple negative breast cancer is defined as:
- •negative for ER and PR (IHC nuclear staining < 10%).
- •Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and FISH without amplification).
- •Clinically evaluable lesions: The presence of lesions that could be evaluated by ultrasound, molybdenum target or magnetic resonance imaging (optional) was within 1 month before randomization.
- •The function examination of organs/bone marrow showed no contraindication within 1 month before chemotherapy.
- •The absolute value of neutrophil count ≥2.0 × 109 / L.
- •The value of hemoglobin ≥100g/L.
- •Platelet count ≥100 × 109/L.
- •Total bilirubin < 1.5 ULN (normal value online).
- •Creatinine < 1.5 × ULN.
- •AST/ALT < 1.5 × ULN.
- •The EF value of echocardiography≥55%.
- •The serum pregnancy test was negative for fertile woman within 14 days before randomization..
- •Informed consent.
排除标准
- •Metastatic breast cancer.
- •Before entering the clinical trial, patients had received chemotherapy, endocrine therapy, targeted therapy, radiotherapy and so on.
- •The patient had dual primary malignancies, except for skin cancer, which was treated.
- •Combined with other serious and uncontrollable medical diseases, the researchers judged that the disease had chemotherapy contraindications.
研究组 & 干预措施
TAC regimen group
The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle.
干预措施: Docetaxel +doxorubicin+ cyclophosphamide (Drug)
TP regimen group
The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.
干预措施: Docetaxel +Cisplatin (Drug)
结局指标
主要结局
The pathological complete remission rate (pCR rate)
时间窗: Immediately after surgery
Pathological complete response rate (PCR rate), which means there is no invasive cancer (i.e. ypT0/is, ypN0) in the excised specimen (breast+lymphnode) following neoadjuvant chemotherapy and surgery.
次要结局
- Event free survival rate (EFS)(5 years after surgery)
- Clinical response rate (CRR)(before breast cancer surgery)
- Breast -conserving rate(up to 24 weeks)
- Number of adverse events and serious adverse events(After each cycle of chemotherapy (21 days as 1 cycle))
研究者
Zhenzhen Liu
Director
Henan Cancer Hospital