Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor positive breast cancer patients

Phase II multicenter 1:1 randomized clinical trial Total 208 patients

Primary endpoint Clinical response rate

Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy Toxicity profile of neoadjuvant letrozole, metformin

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Letrozole; Metformin

Criteria

Inclusion Criteria:

• Estrogen receptor positive breast cancer

• Clinically measurable tumor size(stage II/III)

• No evidence of distant metastasis

• Postmenopause women 'Age≥60yr' OR 'previous bilateral oophorectomy' OR 'FSH>30 with no bleeding history within 1yr'

• ECOG 0-2

• Adequate hepatorenal, bone marrow function 'serum Cr<1.4mg/dL' AND 'Bilirubin< upper limit of normal x 1.5 AND 'AST/ALT < upper limit of normal x 1.8 AND 'ALP < upper limit of normal x 1.8 AND 'Hemoglobin >10 g/dL' AND 'ANC >1,500/mm3' AND 'Platelet >100,000/mm3'

• Spontaneous signed into the written informed consent

Exclusion Criteria:

• Who does not meet the above inclusion criteria

• History of other carcinoma

• Uncontrolled infection

• History of psychiatric, epileptic disease

• Male breast cancer

• Diabetes 'HbA1c≥6.5' OR 'FBS≥126mg/dL'

• Hypersensitivity or intolerance to metformin

• Risk of metformin associated lactic acidosis 'Congestive heart disease of NYHA Class llll/IV' OR 'History of other acidosis' OR 'Alcohol intake more than either 3 bottles beer OR 1 bottle Soju'

• During medication of metformin, sulfonylureas, thiazolidinediones, insulin

• Diffuse microcalcification in mammogram

• Multiple OR bilateral OR inflammatory breast cancer

• Chemotherapy or endocrine therapy within 2yr due to history of breast cancer