Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Metformin with standard Neo-Adjuvant chemotherapy: Tab Metformin - 850mg PO twice daily for 18-22 weeks
Control Intervention1: standard Neo-adjuvant chemotherapy: standard Neo-adjuvant
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion 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 available 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the pathological complete response rates(ypT0ypN0) in each arm.Timepoint: 18-22 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pathological complete response rates in predefined subsets of HER2 positive and triple negative breast cancer 2. Clinical Response rates in each arm 3. Patient reported outcomes in each arm (ESAS-r Scale) 4. Breast conservation surgery rates in each arm 5. Incidence and severity of adverse events in both armsTimepoint: 18-22 weeks | — |
Countries
India
Contacts
Public ContactAkash Kumar
AIIMS, New Delhi
Outcome results
None listed