Comparison of Oral Metronomic Maintenance Therapy vs Capecitabine maintenance in newly treated, non-metastatic TNBC patients after completion of standard treatment along with an exploratory study to asses if tumor DNA/cells can be used as biomarker to predict probability of recurrence.
Phase 3
- Conditions
- Health Condition 1: C501- Malignant neoplasm of central portion of breast
- Registration Number
- CTRI/2022/12/047995
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Non metastatic locally advanced or node positive TNBC
2. Eastern cooperative oncology group performance status 0-2
3. Within 1 month of completion of Standard Therapy consisting of Chemotherapy (Anthracycline & Taxane based); Surgery; +/- RT
4. Able to understand and sign informed consent form
Exclusion Criteria
1. Synchronous or metachronous malignancy
2. Uncontrolled comorbidities
3. Pregnancy and lactation
4. Patient who have not received standard therapy for TNBC or are referred > 1 month after completion of standard therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method comparison of the disease-free survival (DFS) in patients who have received oral MMT v/s those who have received Cape maintenanceTimepoint: 1. Study duration: 10 years <br/ ><br>2. Recruitment: 7 years <br/ ><br>3. Follow up: 3 years after enrolment of last patient <br/ ><br>
- Secondary Outcome Measures
Name Time Method