A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer

Phase 3

Completed

Brief Summary: This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metformin to treat breast cancer, although they have approved its use in this clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.

Detailed Description: This is a multicenter study. Patients are stratified according to hormone-receptor status (estrogen receptor- and/or progesterone receptor- positive vs both receptors negative), body mass index (≤ 30 vs \> 30 kg/m²), HER2 status (positive vs negative), and prior chemotherapy (any vs none). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). 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 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

Blood and tumor samples are collected periodically for correlative studies.

Patients may complete quality-of-life, physical activity, and diet questionnaires at baseline and at 6, 12, 24, 36, 48, and 60 months. (Sub-set of patients).

After completion of study treatment, patients are followed annually.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm I	metformin hydrochloride	Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
Arm II	placebo	Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Invasive Disease-free Survival in Hormone Receptor (ER and PgR) Positive Sub-groups	5 years	Invasive disease-free survival (IDFS) is defined as percentage of patients without documented development of ipsilateral and contralateral invasive breast tumour, local/regional invasive recurrence, distant recurrence, death from any causes. If a subject has not had invasive disease or died at the time of data cut-off for this final analysis, IDFS was censored on the date of last follow-up.
Invasive Disease-free Survival	5 years	Invasive disease-free survival (IDFS) is defined as the percent of patients without documented development of ipsilateral and contralateral invasive breast tumour, local/regional invasive recurrence, distant recurrence, death from any causes. If a subject has not had invasive disease or died at the time of data cut-off for this final analysis, IDFS was censored on the date of last follow-up.

Secondary Outcome Measures

Name	Time	Method
Breast Cancer-specific Mortality	10 years	Patients who died from breast cancer
Overall Survival	10 years	Number of patients who died from any causes.
Distant Relapse-free Survival	5 years	Distant Relapse Free Survival (DRFS) is defined as the percentage of patients without any documented distant recurrence, death from breast cancer, death from a non breast cancer cause or death from an unknown cause. If a subject has not had distant DRFS event nor died at the time of data cut-off for this analysis, DRFS will be censored on the date of last disease assessment.

Locations (343): Providence Alaska Medical Center
🇺🇸
Anchorage, Alaska, United States
Fairbanks Memorial Hospital
🇺🇸
Fairbanks, Alaska, United States
Pinnacle Oncology Associates
🇺🇸
Scottsdale, Arizona, United States
Mayo Clinic in Arizona
🇺🇸
Scottsdale, Arizona, United States
Arizona Cancer Center at University Medical Center North
🇺🇸
Tucson, Arizona, United States
University of Arizona Health Sciences Center
🇺🇸
Tucson, Arizona, United States
Kaiser Permanente-Deer Valley Medical Center
🇺🇸
Antioch, California, United States
Alta Bates Summit Medical Center-Herrick Campus
🇺🇸
Berkeley, California, United States
Enloe Medical Center
🇺🇸
Chico, California, United States
Glendale Memorial Hospital and Health Center
🇺🇸
Glendale, California, United States
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Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States