Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT05982886
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1093
-
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
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No evidence of active other malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of advanced BC
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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
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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)
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of tests for patients with CDK4/6 inhibitor treatment Up to approximately 6 years Analytical method used for PIK3CA evaluation Up to approximately 6 years Number of patients with PIK3CA mutations Up to approximately 6 years Time from advanced BC diagnosis to first PIK3CA evaluation Up to approximately 6 years Type of biopsy Up to approximately 6 years Time from first BC diagnosis to first PIK3CA evaluation Up to approximately 6 years Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation Up to approximately 6 years Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation Up to approximately 6 years Year of (first, where applicable) PIK3CA evaluation Up to approximately 6 years Result of PIK3CA evaluation (negative, positive, unknown) Up to approximately 6 years Type of tissue sample, for patients who had tissue biopsy Up to approximately 6 years Source of tissue sample, for patients who had tissue biopsy Up to approximately 6 years
- Secondary Outcome Measures
Name Time Method Number of patients per supportive treatment Up to approximately 6 years Age at advanced breast cancer diagnosis Up to approximately 6 years Stage when patients were diagnosed with BC Up to approximately 6 years Number of patients with known metastatic sites Up to approximately 6 years Weight Up to approximately 6 years Performance as assessed by Karnofsky Performace Scale Up to approximately 6 years The Karnofsky Performance Scale is a measure of functional impairment.
Height Up to approximately 6 years Number of patients per line of treatment Up to approximately 6 years Time from advanced diagnosis to initiation of lines of treatment Up to approximately 6 years Number of patients per systemic therapy Up to approximately 6 years Number of patients per stage of cancer Up to approximately 6 years Number of patients per treatment sequence Up to approximately 6 years Body mass index (BMI) Up to approximately 6 years Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale Up to approximately 6 years The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States