Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
NCT ID: NCT01589367
Last Updated: 2018-09-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
208 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-05-31
Study Completion Date
2018-08-31
Brief Summary
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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 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
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Detailed Description
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To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients
Conditions
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Hormone Receptor Positive Malignant Neoplasm of Breast
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Arm1_ Metformin
Letrozole with concurrent metformin
Group Type
EXPERIMENTAL
Metformin
Intervention Type
DRUG
Metformin HCl 500mg(morning/evening) PO daily x 1week Metformin HCl 1000mg(morning)and 500mg(evening)PO daily x 1week Metformin HCl 1000mg(morning/evening) PO daily x 22weeks
Arm 2_ Letrole alone
Letrozole with placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Letrozole 2.5mg PO daily + Placebo 1 tablet PO 2/day x 1week Letrozole 2.5mg PO daily + Placebo 2 tablet+ 1 tablet PO x 1 week Letrozole 2.5mg PO daily + Placebo 2 tablet PO 2/day x 22 weeks
Interventions
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Metformin
Metformin HCl 500mg(morning/evening) PO daily x 1week Metformin HCl 1000mg(morning)and 500mg(evening)PO daily x 1week Metformin HCl 1000mg(morning/evening) PO daily x 22weeks
Intervention Type
DRUG
Placebo
Letrozole 2.5mg PO daily + Placebo 1 tablet PO 2/day x 1week Letrozole 2.5mg PO daily + Placebo 2 tablet+ 1 tablet PO x 1 week Letrozole 2.5mg PO daily + Placebo 2 tablet PO 2/day x 22 weeks
Intervention Type
DRUG
Other Intervention Names
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Arm1_Metformin_experimental
Arm2_Letrozole alone_Placebo
Eligibility Criteria
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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
* 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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Seoul National University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Wonshik Han, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Site Status
Countries
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South Korea
References
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Reference Type
DERIVED
Other Identifiers
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KBCSG 013
Identifier Type: -
Identifier Source: org_study_id
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