Clinical Phase II, Randomized, Double Blind Trial, to Evaluate the Efficacy of Metformin and Chemotherapy Versus Placebo Nad Chemotherapy in Neoadjuvant Setting for Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pathologic complete response
研究概览
简要总结
Background Obesity and overweight are well known risk factors for breast cancer and also are associated with higher recurrence and mortality rates.
Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms of pathologic complete response in comparison with placebo plus the same chemotherapy regimen Design: Randomized, double blind, clinical trial. This study will be performed at National Cancer Institute of Mexico City, at breast cancer unit.
Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate.
After completion of chemotherapy all patients will have a breast surgery to assess pathologic response.
Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR
详细描述
Definitions Luminal A: tumors ER + PR + HER2 Negative and Ki67 <14% Luminal B: tumors ER +/-, PR +/-, HER2 negative and Ki67 >15% Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR
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
- Double (Participant, Investigator)
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 older than 18 years old and younger than 70 years old
- •Invasive breast cancer confirmed by core biopsy, any histology
- •Tumor ≥2 cm and/or lymph node positive (proven by FNA)(T2-4b, N0-3, M0)
- •Must have ER/PR positive and HER2 negative
- •Must have full staging and extent disease and clinically and radiographically tumor measure
- •Without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)
- •Normal liver, kidney and blood tests
- •Performance Status ECOG 0-2 o Karnofsky ≥70%
- •Fasten glucose levels <125 mg/dl
- •Signed consent
排除标准
- •Previous use of metformin for any indication
- •Presence of Diabetes Mellitus
研究组 & 干预措施
Metformin
Patients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o.
干预措施: Metformin (Drug)
结局指标
主要结局
pathologic complete response
时间窗: pCR will be assesed after 24 weeks of treatment
to assess the efficacy in terms of pahtologic complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy based on Paclitaxel followed by FAC, combined with metformin or placebo
次要结局
- Safety analysis(after 24 treatment weeks')
- Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy(after 24 treatment weeks')
- To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response(safter 24 treatment weeks')
研究者
Claudia Arce Salinas
Medico Especialista
Instituto Nacional de Cancerologia de Mexico