CTRI/2022/12/047995
Not yet recruiting
Phase 3
Randomized, multi-centric trial of Oral Metronomic Maintenance Therapy (OMMT) vs Capecitabine (Cape) maintenance in newly diagnosed, locally advanced and/or node positive, non-metastatic triple negative breast cancer (TNBC) patients after the completion of standard therapy along with an exploratory study to assess if circulating tumor DNA (ctDNA) and/or circulating tumor cells (CTCs) can be used as a biomarker to predict the probability of recurrence.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C501- Malignant neoplasm of central portion of breast
- Sponsor
- Tata Memorial Hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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