CTRI/2022/05/042576RecruitingPhase 2
Metformin with neoadjuvant chemotherapy inlocalized Triple negative and Her2neu positive breastcancer a-prospective phase-2 open label randomisedcontrolled trial - McBETH
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1 Histologically confirmed invasive breast cancer, localized HER 2 positive or triple
- •negative breast cancer
- •2 Haematology investigations have been completed within 28 days prior to randomisation and results are
- •3 Biochemistry investigations have been completed within 28 days prior to
- •randomisation and values are within the parameters required by the protocol
- •(AST less than 1.8 times upper limit of normal, ALT less than 1.8 times Upper limit of normal, Alkaline Phosphatase less than 2 times ULN,
- •Serum Creatinine less than 1.3mg/dL (GFR > 60ml/min/1.73m2, Serum Bilirubin less than 1.4 times ULN
- •4 ECOG Performance Status of less than or equal to 2 at baseline evaluation visit within 28
- •days prior to randomisation
- •6 Chemotherapy naive
- •7 Written informed consent
Exclusion Criteria
- •1. Known diabetes (type1 or type 2) or baseline HBA1c more than or equal to 6.5%
- •2. Locally Recurrent breast cancer
- •3. Bilateral breast cancer
- •4. Male breast cancer
- •5. Multiple malignancies
- •6. Prior treatment for breast cancer
- •7. Active infection or uncontrolled medical condition
- •8. Cardiac arrhythmia, uncontrolled congestive heart failure or acute MI within the previous 6 months.
- •9. Pregnant or breast feeding females or those not willing for contraception.
- •10. Known hypersensitivity or intolerance to metformin
- •11. Concurrent participation in any other trial
Investigators
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