Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Comparing two different schedules of capecitabine groups (A and B) with observation group (C): Capecitabine at a dose of 650 mg/m2 twice a day by mouth for 1 year without interruption
Sponsors
Pt B D Sharma Postgraduate Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison in disease-free survivalTimepoint: At the end of 1-,3- and 5-years | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison in Overall survival and Adverse effects between three groupsTimepoint: At the end of 1-,3- and 5-years | — |
Countries
India
Contacts
Public ContactDr Shailley
Pt B D Sharma Postgraduate Institute of Medical Sciences
Outcome results
None listed