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Metformin with Neoadjuvant Chemotherapy in Early Breast Cancer
NCT04387630Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2020
- Primary completion
- Jun 2022
- Countries
- 1
- Sponsor
- Mansoura University
- Conditions
- breast cancer
01
Overview
Phase 3, randomised, double-blind trial of liquid metformin (Aspargo Labs) in breast cancer (2 arms), sponsored by Mansoura University. Primary endpoint: Clinical Response Rate at 3 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Metformin Arm
Metformin + Neoadjuvant Chemotherapy (AC or AC-T)
Placebo Arm
Placebo + Neoadjuvant Chemotherapy (AC or AC-T)
03
Who it enrols
Non-diabetic patients with histologically proven early breast cancer (no distant metastasis) who are candidates for neoadjuvant chemotherapy and have normal renal and liver functions.
04
Endpoints
Primary
Clinical Response Rate
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