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.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/047995

Enrollment

382

Registered

2022-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C501- Malignant neoplasm of central portion of breast

Interventions

Intervention1: Oral Metformin, Methotrexate, and Cyclophosphamide Maintenance(OMMT): On completion of standard therapy patients with residual disease Patients randomized to the intervention group will

Eligibility

Inclusion criteria

Inclusion criteria: -Non metastatic locally advanced T3 orT4 with N0 or N1 or any T with N2 or N3 as per AJCC 8th edition 2017 or any node positive TNBC with residual disease after completion of standard therapy. -Eastern cooperative oncology group performance status 0 to 2 -Within 1 month of completion of Standard Therapy consisting of Chemotherapy Anthracycline & Taxane based Surgery with or without radiotherapy. -Hb more than or equal to 8 g per dL, Platelets more than or equal to 100000 per L, ANC more than or equal to 1000 per L -Bilirubin less than or equal to 1.5 into ULN, AST and ALT less than or equal to1.5 into ULN -Estimated GFR based on Cockcroft gault formula more than or equal to 51 mL per min minimum creatinine level of 0.7 mg per dL will be taken -Able to understand and sign informed consent form

Exclusion criteria

Exclusion criteria: -Synchronous or metachronous malignancy -Metastatic breast cancer -Bilateral breast cancer -Patients currently receiving or planned for olaparib therapy -Uncontrolled comorbidities -Pregnancy and lactation -Patient who has not received standard therapy for TNBC or are referred more than 1 month after completion of standard therapy

Design outcomes

Primary

Measure	Time frame
To compare the disease-free survival (DFS) in patients with residual disease who have received oral MMT v/s those who have received Cape maintenance.Timepoint: 1. Study duration: 7 years 2. Recruitment: 2 years 3. Follow-up: 5 years after enrolment of the last patient	—

Secondary

Measure	Time frame
To compare the overall survival (OS) in patients who have received Oral MMT v/s those who have received Cape maintenance. Timepoint: 1. Study duration: 7 years 2. Recruitment: 2 years 3. Follow-up: 5 years after enrolment of the last patient ;To determine the proportion of patients with ctDNA positivity and presence of CTC after completion of standard treatment Timepoint: 1. Study duration: 7 years;To compare disease free survival in those who have received OMMT vs those who have received Cape maintenance in the cohort of the patients with ctDNA positivity or presence of CTC (at the end of standard therapy)Timepoint: 1. Study duration: 7 years 2. Follow-up: 5 years after enrolment of the last patient;To compare overall survival in those who have received OMMT vs those who have received Cape maintenance in the cohort of the patients with ctDNA positivity or presence of CTC (at the end of standard therapy)Timepoint: 1. Study duration: 7 years 2. Recruitment: 2 years;To assess & compare the tolerance & toxicity of OMMT vs Cape maintenanceTimepoint: 1. Study duration: 7 years 2. Recruitment: 2 years 3. Follow-up: 5 years after enrolment of the last patient	—

Measure

Time frame

To compare the overall survival (OS) in patients who have received Oral MMT v/s those who have received Cape maintenance. Timepoint: 1. Study duration: 7 years 2. Recruitment: 2 years 3. Follow-up: 5 years after enrolment of the last patient ;To determine the proportion of patients with ctDNA positivity and presence of CTC after completion of standard treatment Timepoint: 1. Study duration: 7 years;To compare disease free survival in those who have received OMMT vs those who have received Cape maintenance in the cohort of the patients with ctDNA positivity or presence of CTC (at the end of standard therapy)Timepoint: 1. Study duration: 7 years 2. Follow-up: 5 years after enrolment of the last patient;To compare overall survival in those who have received OMMT vs those who have received Cape maintenance in the cohort of the patients with ctDNA positivity or presence of CTC (at the end of standard therapy)Timepoint: 1. Study duration: 7 years 2. Recruitment: 2 years;To assess & compare the tolerance & toxicity of OMMT vs Cape maintenanceTimepoint: 1. Study duration: 7 years 2. Recruitment: 2 years 3. Follow-up: 5 years after enrolment of the last patient

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Countries

India

Contacts

Public ContactDr. Anbarasan Sekar

Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre

anbarasan157@gmail.com8124227205

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026