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Phase II Randomized Study of Neoadjuvant Metformin Plus Letrozole vs Placebo Plus Letrozole for ER-positive Postmenopausal Breast Cancer


Phase 2
18 Years
80 Years
Open (Enrolling)
Female
Hormone Receptor Positive Malignant Neoplasm of Breast

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Trial Information

Phase II Randomized Study of Neoadjuvant Metformin Plus Letrozole vs Placebo Plus Letrozole for ER-positive Postmenopausal Breast Cancer


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


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

Type of Study:

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

Outcome Measure:

Clinical response rate

Outcome Description:

Comparing with RECIST 1.1 From baseline to 24week(after completing medication, preoperatively)

Outcome Time Frame:

24week(after completing medication, preoperatively)

Safety Issue:

Yes

Principal Investigator

Wonshik Han, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

South Korea: Institutional Review Board

Study ID:

KBCSG 013

NCT ID:

NCT01589367

Start Date:

May 2012

Completion Date:

April 2015

Related Keywords:

  • Hormone Receptor Positive Malignant Neoplasm of Breast
  • neoadjuvant endocrine therapy
  • metformin
  • postmenopausal breast cancer
  • Breast Neoplasms
  • Neoplasms

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