Breast Cancer
Conditions
Keywords
stage IA breast cancer, stage IB breast cancer, estrogen receptor-positive breast cancer
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.
Interventions
OTHERlaboratory biomarker analysis
Correlative sciences
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with stage I breast cancer (T1N0M0) and estrogen-receptor status positive or unknown * Patients underwent lumpectomy with negative margins and were clinically node-negative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size | baseline |
| Lymph node status | baseline |
| Treatment group associated with PIK3CA expression | baseline |
| Breast cancer-free interval for patients with PIK3CA-mutated tumors | baseline |
| Estrogen receptor status | baseline |
Secondary
| Measure | Time frame |
|---|---|
| Breast cancer specific survival associated with PIK3CA expression | baseline |
| Overall survival associated with PIK3CA | baseline |
Outcome results
None listed