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

Novartis Pharmaceuticals1,093 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,093

Conditions

Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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) Exclusion Criteria: None