Metformin trials in breast cancer

Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational. Detailed Description:. Arm I: Patients receive oral metformin hydrochloride twice daily once daily in weeks Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive oral placebo twice daily once daily in weeks MedlinePlus related topics: Breast Cancer.

Drug Information available for: Metformin Metformin hydrochloride. FDA Resources. Arms and Interventions. Patients receive oral placebo twice daily once daily in weeks Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Eligibility Criteria: Subjects must have histologically confirmed invasive breast cancer and be enrolled in the trial within 12 months after the first histologic diagnosis of invasive breast cancer. A core biopsy interpreted as invasive cancer meets this criterion; otherwise, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer biopsy, lumpectomy or mastectomy.

Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery. Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither violates the eligibility criteria.

HER2 status must be known. All other results will be considered negative. Patients must have had a bilateral mammogram within 12 months prior to randomization, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required.

Subjects with bilateral total mastectomies and no mammogram within 12 months prior to randomization must, instead, have a physical examination of the chest wall to ensure there is no residual or recurrent disease at the time of randomization. The date of this examination is used in place of the mammogram date on the eligibility checklist. Chest X-Ray, 2 view or Chest CT is mandatory Bone scans with x-rays of abnormal areas are required only if there are signs or symptoms of metastatic disease Abdominal imaging is required only if there are signs or symptoms of metastatic disease Hematology investigations WBC, Granulocytes, Platelets, Hemoglobin have been completed within 28 days prior to randomization and results are available.

Biochemistry investigations have been completed within 28 days prior to randomization and values are within the parameters required by the protocol. Subjects must be accessible for treatment and follow-up. Investigators must assure themselves the subjects randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given.

A copy of the initial full board REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization or registration.

Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records see Section 16 for further details. For the first eligible English or French-speaking subjects only sub-set enrollment completed NOV04 : Subject is able i. The baseline assessment must already have been completed at the time of enrollment.

Inability illiteracy in English or French, loss of sight or other equivalent reason to complete questionnaires will not make the patient ineligible for the study; however, ability but unwillingness to complete the questionnaires will make the patient ineligible.

Once the target number of subjects is achieved, this criterion will no longer need to be fulfilled. Sub-set enrollment completed NOV English-speaking subjects who have completed the Quality of Life Questionnaire who are able i. Inability illiteracy in English, loss of sight or other equivalent reason to complete questionnaires will not make the patient ineligible for the study; however, ability but unwillingness to complete the questionnaires will make the patient ineligible.

This component of the study will close at the same time as the Quality Of Life sub-study. Closed to new patient enrollment as of NOV Subjects with locally recurrent or metastatic breast carcinoma. Subjects with prior invasive breast cancer at any time are not eligible. Subjects whose axillary node status is unknown. Both metformin and the dummy drug are tablets. You take 1 tablet daily for 4 weeks.

You then take 2 tablets a day, 1 in the morning and 1 tablet in the evening. You take your tablets with food. If you agree to take part in this trial you will have 3 extra blood tests to measure how much sugar and insulin is in your blood a fasting blood test. Before these blood tests you must not eat or drink anything other than water for 12 hours. If you agree to take part in this study, the researchers will ask for a sample of tissue taken from when you had surgery to remove your cancer.

You can still take part in the trial. During treatment you see the doctor after 6 months, 1 year and then once a year after that. You have a physical examination and blood tests at each appointment. You have a fasting blood test at 6 months and 5 years. You have a mammogram every year. Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified. I wanted to try new cancer treatments and hopefully help future generations.

Skip to main content. A trial looking at the drug metformin for early breast cancer Please note - this trial is no longer recruiting patients. Cancer type: Breast cancer.

Status: Closed. Conclusion and future vision According to the published results of clinical, experimental and animal models, the effectivity of metformin in cancer treatment is influenced by four different factors: 1 hypoxia of cancer cells;, 2 amount of cancer stem cells;, 3 intrinsic sensitivity of cells;, and 4 growth and proliferation of cancer cells. Author contributions All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published and agree to be accountable for all aspects of the work.

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