METRONOMIC CAPECITABINE FOR MAINTENANCE IN NON METASTATIC TRIPLE NEGATIVE BREAST CANCER [TNBC] AFTER STANDARD TREATMENT
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess the tolerability & toxicities of Metronomic capacitabine as maintenance
研究概览
简要总结
The rising cancer burden globally in general and in India in particular is a significant health
concern. Breast cancer forms a majority of this burden in females of which triple negative
molecular subtype particularly shows poor response and increased relapse rates and distant
metastases after standard combined modality approach of surgery, chemotherapy and
radiotherapy . A number of drugs are being tried in neoadjuvant, adjuvant and metastatic settings in triple negative breast cancers to cater to the huge unmet need in treatment modalities that could be offered to this notorious entity. Most of these drugs, barring a few for neoadjuvant setting, have not been able to have an established role.
Capecitabine can be offered to most patients of triple negative breast cancers after standard
therapy, owing to its availability and affordability. Addition of metronomic capecitabine in
adjuvant setting after standard therapy in TNBC patients has potential particularly for developed countries like India. Ambala district has the second highest incidence of breast cancer in the state of Haryana and a single institution study from our institute showed the incidence of TNBC to be as high as 43%.
This study is being taken up to assess the tolerability of metronomic capecitabine as
maintenance therapy post standard therapy in non metastatic TNBC patients while establishing the disease free survival of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age 25 -75 yrs.
- •Karnofsky performance status more than 70
- •Completed planned standard therapy (Surgery, Chemotherapy- neoadjuvant/ adjuvant, Radiotherapy)
- •Proven to be non metastatic after standard treatment also by imaging with whole body PET-CT before starting tab.
- •Capecitabine.
- •No other synchronous malignancy.
排除标准
- •Age <25 yrs and >75 yrs.
- •With history of treatment for Breast cancer or for any other Malignancy
- •Deranged liver and kidney functions
- •Deranged coagulation profile [bleeding time, clotting time, PT-INR]
- •Known hypersensitivity to capacitabine or 5-Flourouracil
- •Metastatic Disease at presentation or after completion of standard therapy.
结局指标
主要结局
To assess the tolerability & toxicities of Metronomic capacitabine as maintenance
时间窗: Tolerability and Toxicities assessed ever month for 12 months
therapy [post standard treatment] in non-metastatic TNBC patients
时间窗: Tolerability and Toxicities assessed ever month for 12 months
次要结局
- To establish the Disease free survival of these patients at 2 years(To establish the Disease free survival of these patients at 2 years)