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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01589367
First received: April 17, 2012
Last updated: November 18, 2015
Last verified: June 2015
April 17, 2012
November 18, 2015
May 2012
April 2016   (Final data collection date for primary outcome measure)
Clinical response rate [ Time Frame: 24week(after completing medication, preoperatively) ]
Comparing with RECIST 1.1 From baseline to 24week(after completing medication, preoperatively)
Same as current
Complete list of historical versions of study NCT01589367 on ClinicalTrials.gov Archive Site
  • Pathologic complete response rate [ Time Frame: Postoperation(within 26weeks after starting medication) ]
  • Changes of Ki67(%) [ Time Frame: Baseline-4week(second core needle biopsy) ]
  • Breast conservation rate [ Time Frame: Baseline-postoperation(within 26weeks after starting medication) ]
  • Breast density change [ Time Frame: Baseline-24week(after completing medication, preoperatively) ]
  • Toxicity profile of letrozole and metformin [ Time Frame: throughout the study ]
Same as current
Not Provided
Not Provided
 
Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
Phase II Randomized Study of Neoadjuvant Metformin Plus Letrozole vs Placebo Plus Letrozole for ER-positive Postmenopausal Breast Cancer

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

To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hormone Receptor Positive Malignant Neoplasm of Breast
  • 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
  • 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
  • Experimental: Arm1_ Metformin
    Letrozole with concurrent metformin
    Intervention: Drug: Metformin
  • Placebo Comparator: Arm 2_ Letrole alone
    Letrozole with placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
208
April 2017
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01589367
KBCSG 013
Yes
Not Provided
Not Provided
Not Provided
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Wonshik Han, MD PhD Seoul National University Hospital
Seoul National University Hospital
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP