STUDY PROTOCOL article
Front. Oncol.
Sec. Breast Cancer
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1561692
Neoadjuvant chemotherapy with or without Metformin in early stage or locally advanced (nonmetastatic) triple negative breast cancer -An open label Phase 2 Randomized controlled trial
Provisionally accepted
Vinod Ramani*
Radheshyam Naik- Sammprada cancer hospital,, Bangalore, India
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Background: TNBC is more prevalent among the younger age group and is the most aggressive form. Women with TNBC phenotype have a 19% lower 5-year overall survival and 18% lower disease-free survival than their non-TNBC counterparts(1). Hence, extensive research is essential for the development of treatment modalities with high efficacy. Metformin is a widely used anti-diabetic drug. The research work has potential implications for re-purposing metformin in the clinical management of TNBC.Methods: The study design includes a Phase 2 randomized clinical trial of TNBC, with metformin given for the intervention arm and placebo oral tablet for the non-intervention arm. 418 breast cancer patients are randomized with a parallel assignment model (209 each for intervention and control arm). This is an open label trial where the primary purpose is treatment, and adheres to the SPIRIT reporting guidelines. The trial will be initiated during Jan 2025 and is expected to complete by May 2027.Discussion: The clinical benefit, pathological response rate and radiological response will be measured after 4 ½ to 6 months of initiating treatment. The study will assess the recurrence free survival (at intervals of 6 months) and overall survival at 2 years from treatment initiation. Patients who respond to the intervention are expected to have a >50% decrease in the size of primary tumor without appearance of new lesions. RECIST v1.1 criteria is used to determine the objective tumor response for target lesions.
Keywords: Metformin, survival analysis, Triple negative breast neoplasm, remission, Neoadjuant
Received: 16 Jan 2025; Accepted: 23 May 2025.
Copyright: © 2025 Ramani and Naik. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Vinod Ramani, Sammprada cancer hospital,, Bangalore, India
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