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Report for Clinical Trial NCT01101438

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

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.

NCT01101438 Breast Cancer
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

2 Interventions

Name: metformin hydrochloride

Description: Given orally
Type: Drug
Group Labels: 1

Arm I

Name: placebo

Description: Given orally
Type: Other
Group Labels: 1

Arm II

Primary Outcomes

Measure: Invasive disease-free survival in hormone receptor (ER and PgR) negative and positive (ER and/or PgR) sub-groups

Time: 10 years

Secondary Outcomes

Measure: Overall survival

Time: 10 years

Measure: Distant relapse-free survival

Time: 10 years

Measure: Breast cancer-free interval

Time: 10 years

Measure: Long-term clinical and laboratory safety

Time: 10 years

Measure: Relevant medical endpoints (new diabetes, new cardiovascular hospitalizations)

Time: 10 years

Measure: Health-related quality of life, physical activity, and diet

Time: 10 years

Measure: Change in body mass index

Time: 10 years

Measure: Correlative science outcomes

Time: 10 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 P13K

- Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors, or involving P13K inhibitors (at the time of randomization)*. --- P13K ---

HPO Nodes