Status:
COMPLETED
Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This was a retrospective observational study of patients with advanced breast cancer (BC). This non-interventional study was conducted using discrete structured data and medical record abstraction, if...
Eligibility Criteria
Inclusion
- Patients who met the following criteria were eligible for abstraction:
- Newly diagnosed advanced BC between 01 January 2015, and 30 June 2020
- Evaluated for a PIK3CA mutation and identified PIK3CA gene status
- No evidence of active other malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of advanced BC
- At least 18 years of age at the time of first diagnosis of BC
- Patients may be alive or deceased at the time of abstraction
- Not ever enrolled in the following interventional clinical trials evaluating PI3K inhibitors:
- SOLAR-1 trial (NCT0243731) evaluating alpelisib (BYL719)
- BELLE-2 or BELLE-3 trial (NCT01610284, NCT01633060) evaluating buparlisib (BKM120)
- SANDPIPER trial (NCT02340221) evaluating taselisib (GDC-0032)
Exclusion
- None
Key Trial Info
Start Date :
January 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
1093 Patients enrolled
Trial Details
Trial ID
NCT05982886
Start Date
January 15 2021
End Date
April 1 2021
Last Update
August 9 2023
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936