SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT01101438

Developed by Shray Alag, 2019.
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

Arm I

Name: placebo

Description: Given orally

Type: Other

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

SNPs

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

HPO:
Breast carcinoma
Genes 51
RAD51 RAD51C RAD51D CDKN2A KRAS MRE11 SLC22A18 STK11 MSH6 KLLN BRIP1 BRCA1 ATR BRCA2 PIK3CA PPM1D POLD1 NTHL1 POLE ESR1 WRN CHEK2 APC BARD1 MLH1 NBN COL14A1 AKT1 PRKN MSH2 FGFR2 IDH1 IDH2 CTNNB1 RB1CC1 PTEN MDM2 AAGAB CDH1 RNF43 PALLD PALB2 OPCML SEC23B TP53 SDHB SDHC SDHD SMAD4 TWIST1 RAD50
Neoplasm of the breast
Genes 73
RAD51 RAD51C RAD51D CDKN2A KRAS CDKN2B CDKN2D MRE11 SLC22A18 STK11 MSH6 RASGRP1 KLLN BRIP1 MGMT BRCA1 LMNA ATR ACD BRCA2 PIK3CA PPM1D POLD1 NTHL1 POLE ESR1 POT1 MC1R MITF WRN CHEK2 APC BARD1 MLH1 PRKAR1A CASP10 NBN PRKCD COL14A1 AKT1 C11ORF95 PRKN RELA MSH2 FGFR2 IDH1 GNAS IDH2 CTNNB1 RB1CC1 PTEN MDM2 FAS FASLG AAGAB CDH1 TERT RNF43 PALLD PALB2 OPCML TERF2IP PRLR SEC23B TP53 SDHB SDHC SDHD SMAD4 BAP1 CDK4 TWIST1 RAD50