Benefit of oral chemotherapy drug Capecitabine by comparing two different dose schedules with observation after standard treatment in triple negative Breast Cancer
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2024/05/066872
- Lead Sponsor
- Pt B D Sharma Postgraduate Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1)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.
4)Patients must have completed work up and staging followed by treatment with standard chemotherapy and surgery and /or radiation therapy.
1)The presence of cancer in bilateral breasts or metastatic disease, other malignant conditions or synchronic multiple cancers.
2)ECOG PS 3 and above.
3)Patients’ refusal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison in disease-free survivalTimepoint: At the end of 1-,3- and 5-years
- Secondary Outcome Measures
Name Time Method Comparison in Overall survival and Adverse effects between three groupsTimepoint: At the end of 1-,3- and 5-years