Metformin with chemotherapy in Triple negative and Her2neu positive breastcancer - a randomisedstudy

Phase 2

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2022/05/042576
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the pathological complete response rates(ypT0ypN0) in each arm.Timepoint: 18-22 weeks

Secondary Outcome Measures

Name	Time	Method
1. Pathological complete response rates in predefined subsets of HER2 positive and <br/ ><br>triple negative breast cancer <br/ ><br>2. Clinical Response rates in each arm <br/ ><br>3. Patient reported outcomes in each arm (ESAS-r Scale) <br/ ><br>4. Breast conservation surgery rates in each arm <br/ ><br>5. Incidence and severity of adverse events in both armsTimepoint: 18-22 weeks