A Multi-Center, Randomized Study of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Neoadjuvant Treatment of Triple-Negative or Her2 Positive Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 102
- 试验地点
- 27
- 主要终点
- pathological complete remission (pCR) rate
研究概览
简要总结
The purpose of this study is to compare the pathological complete response (pCR) rate in triple-negative or Her2 positive breast cancer patients treated with neoadjuvant docetaxel, anthracycline and cyclophosphamide (TAC) or docetaxel and cyclophosphamide (TC) regimen.
详细描述
Breast cancer is the leading cause of cancer in women in China. Neoadjuvant chemotherapy for treatment of locally advanced breast cancer has become a standard therapy. Results from neoadjuvant trials have shown that pathological complete response (pCR) is an independent predictor of outcome. Docetaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Both TC and TAC are effective regimens in the adjuvant setting. The most optimal regimen in the neoadjuvant treatment is however unknown. This is especially true in triple-negative or HER2 positive breast cancer. This study will evaluate the pCR rate of TAC and TC as neoadjuvant treatment for triple-negative or HER2 positive breast cancer.
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
- •Women aged ≥ 18 years and < 70 years
- •Karnofsky performance status (KPS) ≥ 70
- •At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), T2N1 or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)
- •Biopsy specimens are available for ER, PgR and Her2 detection, patients should be with triple negative or Her2 positive breast cancer, Her2 positivity is defined as FISH/CISH Her2 positive or IHC Her2 3+, Triple-negative disease defined as negativity for ER, PgR and Her2
- •Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L
- •An estimated life expectancy of at least 12 months
- •Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
- •Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
- •Written informed consent according to the GCP
排除标准
- •Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
- •Metastatic breast cancer
- •With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
- •Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
- •inadequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL; inadequate renal function (creatinine > 1.0 times UNL and in case of limit value, Creatinine clearance < 60 ml/min)
- •Contraindication for using dexamethasone
- •History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
- •Has peripheral neuropathy ≥ grade 1
- •Patient is pregnant or breast feeding
- •Known severe hypersensitivity to any drugs in this study
- •Treatment with any investigational drugs within 30 days before the beginning of study treatment
研究组 & 干预措施
TAC Arm
six cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide
干预措施: Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide (Drug)
TC Arm
six cycles of neoadjuvant Docetaxel and Cyclophosphamide
干预措施: Docetaxel, cyclophosphamide (Drug)
结局指标
主要结局
pathological complete remission (pCR) rate
时间窗: after 6 cycles of neoadjuvant therapy
次要结局
- clinical response rate(after 6 cycles of neoadjuvant therapy)
- breast conservation therapy (BCT) rate(after surgery)
- disease free survival (DFS) and overall survival (OS)(5-year)
- safety profile(during neoadjuvant therapy)
研究者
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine