None listed
Conditions
Brief summary
This study is to see whether taking the drug metformin in addition to drug aromatase inhibitor can stop cancer cell activity in hormone receptor positive breast cancer in post menopausal women waiting for surgery. Who is it for? This study is open to postmenopausal women aged 18 and over, with Stage 1 or 2 operable invasive breast cancer scheduled for surgery. Further inclusion and exclusion details for this study can be found in the relevant sections in this form. Trial details In this study, you will be randomised to one of two groups. Arm 1 will involve taking 2 weeks of metformin (oral tablets, 1 gm per day) followed by 2 weeks of metformin (oral tablets, 1gm per day) in addition to aromatase inhibitor (oral tablets 1 mg per day Arimidex (trade name) or oral tablets 2.5 mg per day Femara (trade name)) in the lead up to your scheduled surgery. If you are randomised to Arm 2, you will receive 2 weeks of metformin (oral tablets, 1gm per day) followed by 2 weeks of aromatase inhibitor alone (oral tablets 1 mg per day Arimidex (trade name) or oral tablets 2.5 mg per day Femara (trade name).
Interventions
2 weeks of metformin (oral tablets, 1 gm per day) followed by 2 weeks of metformin (oral tablets, 1gm per day) plus aromatase inhibitor (oral tablets 1 mg Arimidex (trade name) or oral tablets 2.5 mg Femara (trade name)) all prior to surgery
Sponsors
Dr Vinod Ganju
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage 1 or 2 operable invasive breast cancer. Estrogen receptor positive (>10% cells) Post-menopausal female Histologically proven invasive adenocarcinoma of the breast through either a core needle biopsy or incisional biopsy Excisional biopsy will not be allowed. Tumour must be confined to either the breast or to the breast and ipsilateral axilla. A complete metastatic staging work-up will be performed prior to definitive surgery, as clinically indicated. Age > =18 years. Karnofsky Performance status index > =80%. Laboratory requirements: (within 28 days prior to registration) Haematology: Neutrophils > =1.5 x 109/L Platelets >=100 x 109/L Haemoglobin > =10 g/dL Hepatic function: Total bilirubin < =1 UNL (patients with a well documented history of Gilbert’s Syndrome are eligible) ASAT (SGOT) and ALAT (SGPT) < =2.5 UNL Alkaline phosphatase < =5 UNL Renal function: Creatinine <= 175 micromol/L (2 mg/dL) Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential. Patients must be postmenopausal defined as: Age >50 y and amenorrheic for 6 months or more Age <50 y and amenorrheic for 12 months or more Prior bilateral oophorectomy Prior hysterectomy and has post menopausal levels of FSH and LH per local institutional standards Age >55 y and prior hysterectomy
Exclusion criteria
Prior or concurrent systemic anticancer therapy for breast cancer (immunotherapy, hormone therapy, biological, or chemotherapy). Prior or concurrent radiation therapy for breast cancer. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment. M1 breast cancer. Diabetic patients currenly treated with metformin. Diet controlled diabetic patients are eligible. Other serious illness or medical condition: Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias, history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent, active uncontrolled infection, active peptic ulcer Current history of any neoplasm other than breast carcinoma. Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped at least 4 weeks prior to registration. Concurrent treatment with other experimental drugs. Current therapy with any hormonal agent such as raloxifene, tamoxifen or other selective oestrogen receptor modulators (SERMs), either for osteoporosis or prevention. Patients must have discontinued these agents at least four weeks prior to registration. Known allergy reactions or excipients used in the study.
Outcome results
None listed