Evaluating the role of Adjuvant Capecitabine by comparing two different dose schedules with observation after standard treatment in triple negative Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Comparison in disease-free survival
研究概览
简要总结
Breast cancer as per Globocan 2020 is the most common cancer globally and known for its heterogeneity.Triple negative breast cancer (TNBC) accounts for approximately 15% of breast cancer cases. Despite newer developments in neoadjuvant/adjuvant chemotherapy prognosis remains a big question mark with 25-35% of the patients developing metastasis within 5 years from diagnosis in TNBC patients.
Capecitabine, a pro-drug of 5- fluorouracil, is an oral chemotherapeutic anti metabolite group of agent which is readily available and its role after standard treatment is yet to establish.Thus we planned to study the benefit in terms of Disease-free and overall survival and adverse effects in TNBC patients.
Studies are scarce in this context and no established dose schedule especially in India,the aim will be to compare three groups with two different schedules of Capecitabine with observation group. It is a single center randomized controlled trial and the primary end point will be disease-free survival and Secondary end points will include overall survival, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with confirmed histopathological diagnosis of triple negative breast cancer (defined as estrogen or progesterone receptor 1+ or 2+ immunohistochemistry intensity in ≤ 10% cells and HER2-negative by immunohistochemistry and/or in situ hybridization) 2)Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 (Annexure I) and complete hemogram, renal and liver function tests are within normal limits 3)Patients who are able to give consent.
- •Patients must have completed work up and staging followed by treatment with standard chemotherapy and surgery and /or radiation therapy.
排除标准
- •The presence of cancer in bilateral breasts or metastatic disease, other malignant conditions or synchronic multiple cancers.
- •ECOG PS 3 and above.
- •Patients’ refusal.
结局指标
主要结局
Comparison in disease-free survival
时间窗: At the end of 1-,3- and 5-years
次要结局
- Comparison in Overall survival and Adverse effects between three groups(At the end of 1-,3- and 5-years)
研究者
Dr Shailley
Pt B D Sharma Postgraduate Institute of Medical Sciences