Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- pathological complete remission (pCR) rate
研究概览
简要总结
The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.
详细描述
Breast cancer is the leading cause of cancer in women in China. Preoperative 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. Paclitaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Platinum complexes, like cisplatin and carboplatin, are active in a wide range of solid tumors. Paclitaxel combined with carboplatin has shown great activity in ovarian and nonsmall- cell lung cancer treatment. In addition, the overall response rate of paclitaxel plus carboplatin was between 53% and 62% in the first-line treatment of metastatic breast cancer. This study will evaluate the pCR rate of weekly paclitaxel plus carboplatin as preoperative treatment for breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 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), large operable (T≥3 cm and N0-1) or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)
- •Biopsy specimens are available for ER, PgR and Her2 analysis
- •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
paclitaxel plus carboplatin (PCb) Arm
4 cycles of neoadjuvant paclitaxel plus carboplatin
干预措施: Paclitaxel, Carboplatin (Drug)
结局指标
主要结局
pathological complete remission (pCR) rate
时间窗: after 4 cycles of preoperative treatment
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(4 months during neoadjuvant therapy)
- clinical response rate(after 4 cycles of preoperative therapy)
- Predictive markers of weekly paclitaxel plus carboplatin(after 4 cycles of preoperative treatment)