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

Seoul National University

Status and phase

Completed

Phase 2

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast

Treatments

Drug: Placebo

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT01589367

KBCSG 013

Details and patient eligibility

About

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

Full description

To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients

Enrollment

208 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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