Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
This study is currently recruiting participants.
Verified December 2012 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01589367
First received: April 17, 2012
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hormone Receptor Positive Malignant Neoplasm of Breast |
Drug: Metformin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase II Randomized Study of Neoadjuvant Metformin Plus Letrozole vs Placebo Plus Letrozole for ER-positive Postmenopausal Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Clinical response rate [ Time Frame: 24week(after completing medication, preoperatively) ] [ Designated as safety issue: Yes ]Comparing with RECIST 1.1 From baseline to 24week(after completing medication, preoperatively)
Secondary Outcome Measures:
- Pathologic complete response rate [ Time Frame: Postoperation(within 26weeks after starting medication) ] [ Designated as safety issue: Yes ]
- Changes of Ki67(%) [ Time Frame: Baseline-4week(second core needle biopsy) ] [ Designated as safety issue: Yes ]
- Breast conservation rate [ Time Frame: Baseline-postoperation(within 26weeks after starting medication) ] [ Designated as safety issue: Yes ]
- Breast density change [ Time Frame: Baseline-24week(after completing medication, preoperatively) ] [ Designated as safety issue: Yes ]
- Toxicity profile of letrozole and metformin [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 208 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm1_ Metformin
Letrozole with concurrent metformin
|
Drug: 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
Other Name: Arm1_Metformin_experimental
|
|
Placebo Comparator: Arm 2_ Letrole alone
Letrozole with placebo
|
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
Other Name: Arm2_Letrozole alone_Placebo
|
Detailed Description:
To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589367
Contacts
| Contact: Wonshik Han, MD PhD | 82-2-2072-1958 | hanw@snu.ac.kr |
| Contact: Jisun Kim, MD | 82-2-2072-0612 | leticeclear@naver.com |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Wonshik Han, MD PhD 82-2-2072-1958 hanw@snu.ac.kr | |
| Contact: Jisun Kim, MD 82-2-2072-0612 leticeclear@naver.com | |
| Sub-Investigator: Jisun Kim, MD | |
Sponsors and Collaborators
Seoul National University Hospital
Investigators
| Principal Investigator: | Wonshik Han, MD PhD | Seoul National University Hospital |
More Information
Publications:
| Responsible Party: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01589367 History of Changes |
| Other Study ID Numbers: | KBCSG 013 |
| Study First Received: | April 17, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
|
neoadjuvant endocrine therapy metformin postmenopausal breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Metformin Letrozole Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013