Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer

Novartis

Status

Completed

Conditions

Breast Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT05982886

CBYL719A0US11

Details and patient eligibility

About

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 needed, from patients treated at Texas Oncology, the designated research organization and a community oncology practice. The first date of a new diagnosis of advanced BC (de novo or progressed to advanced BC) defined the study index date. To allow for an adequate potential duration of follow-up (retrospectively observed) after the index date over which PIK3CA testing and treatment patterns was observed, a minimum follow-up opportunity of 6 months after the diagnosis of advanced BC at the time of data pull and/or abstraction was required.

Enrollment

1,093 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)