Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

The goal of this clinical research study is to learn if metformin can help prevent breast cancer from developing in the unaffected breast.

Metformin was designed to treat patients with diabetes. It may be able to block mammalian target of rapamycin (mTOR) and slow the start and growth of tumors.

Further Study Information

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:

• If you are in Group 1, you will take metformin 2 times a day by mouth with water.

• If you are in Group 2, you will not receive metformin.

You will be given a study drug diary to complete. In the diary, you will record when you take the study drug.

Study Visits:

At Months 2, 4, and 5, you will be called by a nurse and asked about any drugs you are taking and side effects you may be having. You will also be asked to review your drug diary. This call will take about 20 minutes

At Month 3:

• Blood (about 2 tablespoons) will be drawn for routine tests.

• You will be asked about any drugs you may be taking and side effects you may be having.

• Your drug diary will be reviewed.

At Month 6 (or if you leave the study early):

• You will have a fine needle aspirate (FNA) of the breast for biomarker testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.

• Blood (about 2-3 tablespoons) will be drawn for biomarker testing.

• You will be asked about any drugs you may be taking and side effects you may be having.

• Your drug diary will be reviewed.

Length of Study:

You may remain on study for up to 6 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Metformin is FDA approved and commercially available for diabetes control. Its use in breast cancer patients in investigational.

Up to 100 patients will take part in this multicenter study. Up to 75 will be enrolled at MD Anderson.

Eligibility Criteria

Inclusion Criteria:

1. Histological confirmation of estrogen receptor (ER) negative breast carcinoma, stage I, II, or III

2. Completed all adjuvant therapy including (if indicated) endocrine, trastuzumab, radiation therapy

3. Contralateral atypia on random periareolar fine needle aspiration (RPFNA) at least 90 days after completion of adjuvant treatment for breast cancer.

4. At least 18 years of age.

5. Provided written informed consent.

6. Adequate bone marrow function (within last 3 months) Hemoglobin >/= 9 gm/dL. • Absolute granulocyte count 1,500/mm^3 (1.5 * 10^9/L). • Platelets 75,000/mm^3 (100 * 10^9/L).

7. Normal mammogram within 12 months prior to study entry

8. Female: A female is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are post-menopausal); or b. Childbearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. This category includes women with oligomenorrhoea (severe), women who are perimenopausal, and young women who have begun to menstruate), has a negative serum pregnancy test at screening, and agrees to one of the following where considered acceptable to the local IRB/IEC: • Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm). • Abstinence from sexual intercourse from 2 weeks prior to administration of the investigational product, throughout the active study treatment period.

9. (Continued from above) • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject. • Any intrauterine device (IUD). • Barrier methods including diaphragm or condom with a spermicide.

10. Able to swallow and retain oral medication.

11. ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.

12. Serum creatinine < 1.4 mg/dL or calculated creatinine clearance (CrCl) >/= 60 mL/min ( within last 3 months)

13. Aspartate and alanine transaminase (AST or ALT) </= 3 times the upper limit of the reference range (within last 3 months).

14. Has a left ventricular ejection fraction (LVEF) >/= 50%, or >/= lower limit of normal for the institution, based on echocardiogram (ECHO) or multi-gated angiogram (MUGA) (within last 3 months).

15. Normal Hgb A1c

16. Total bilirubin </= 3.0 mg/dL (within last 3 months)

Exclusion Criteria:

1. Heart failure defined as New York Heart Association (NYHA) class III or IV functional status

2. Has evidence of recurrent or metastatic (Stage IV) breast cancer.

3. Is a pregnant or lactating female.

4. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to Metformin

5. Has received treatment with any investigational drug in the previous 4 weeks.

6. Has received chemotherapy, immunotherapy, biologic therapy or endocrine therapy within the past 12 weeks.

7. Contraindication to random periareolar fine needle aspiration (RPFNA) including breast implant(s), bilateral radiation, anticoagulation.

8. Unwillingness to undergo RPFNA.

9. RPFNA that does not demonstrate atypia.

10. Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.

11. Is currently receiving oral steroid treatment (inhaled steroids are permitted)

12. Oral estrogen, progesterone, testosteron therapy within last 3 months.

13. Excessive alcohol intake as determined by the treating physician

14. Known vitamin B12 deficiency

15. Concomitant medications including metformin, sulfonylurea, thiazolidinedione, insulin

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Banu Arun

Principal Investigator

Banu Arun, MD

Ph: 713-792-2817

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01471106
Information obtained from ClinicalTrials.gov on September 05, 2012

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