A Prospective, Belgian Multi-center, Single-arm, Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 18
- 主要终点
- -The rate of pCR in the breast and axilla (ypT0/is, ypN0)
研究概览
简要总结
This is a prospective Belgian, multi-center, open-label, single-arm phase II study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer to evaluate tumor response in the breast and the axilla.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage II-III operable triple negative (ER and PR < 10%; Her2 IHC 0-1 or FISH <2.0) breast cancer in women age >
- •For patients aged 65 or older the G8 geriatric screening test should be > 14 (on a total of 17).
- •Baseline mammography, US. MR of the breast on clinical indication.
- •FNA of suspicious axillary lymph node is indicated
- •Pre-treatment SN biopsy is indicated in clinical N0
- •Measurable loco-regional disease
- •Adequate bone marrow function, defined as
- •Absolute neutrophil count(ANC) >1500*109/L
- •Platelet count >100.000*109/L
- •Adequate liver function defined as
- •Serum(total) bilirubin <1.5*upper limit of normal(ULN), unless the patient has documented Gilbert's Syndrome
- •AST and/or ALT <2.5*ULN
- •Alkaline phosphatase <2.5*ULN
- •Normal cardiac function measured by ultrasound with a left ventricular function > 55%
- •Creatinine clearance > 40 ml/min according to local laboratory standard (MDRD, CDK-epi, Cockroft-Gault, or other established formula to calculate renal function)
排除标准
- •T4d breast tumor
- •Bilateral breast cancer
- •Other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix.
- •Pregnant or lactating patients
研究组 & 干预措施
single-arm
weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer
干预措施: Paclitaxel (Drug)
single-arm
weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer
干预措施: Carboplatinum (Drug)
single-arm
weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer
干预措施: Epirubicin (Drug)
single-arm
weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
-The rate of pCR in the breast and axilla (ypT0/is, ypN0)
时间窗: 20 weeks
次要结局
- Evaluation of progression free survival(20 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03(20 weeks)
- Evaluation of breast-conserving surgery rate(20 weeks)
- Evaluation of overall survival(20 weeks)
- Evaluation of percentage of patients with BRCA1 or BRCA2 in this population.(20 weeks)
- Evaluation of tumor infiltrating lymphocytes on the residual tumor(20 weeks)
- Evaluation of the drug delivery(20 weeks)
- Evaluation of clinical response rate (RECIST 1.1) by mammography and sonography in breast and axilla.(20 weeks)
- genome analysis on tissue samples(20 weeks)
研究者
Dr Fontaine Christel
Principle Investigator
AZ-VUB