Biomarkers in Tissue Samples From Older Women With Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT01346579
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
- Detailed Description
PRIMARY OBJECTIVES:
To assess the relapse free-survival difference between patients with PIK3CA mutated and wild-type (WT) tumors and therefore validate PIK3CA mutation status as an important biomarker in women 70 years or older diagnosed with breast cancer.
OUTLINE:
Previously collected tissue samples are analyzed via mutation analysis of PIK3CA.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 505
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumor size baseline Breast cancer-free interval for patients with PIK3CA-mutated tumors baseline Estrogen receptor status baseline Lymph node status baseline Treatment group associated with PIK3CA expression baseline
- Secondary Outcome Measures
Name Time Method Overall survival associated with PIK3CA baseline Breast cancer specific survival associated with PIK3CA expression baseline