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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PIK3CA positive: HR+ Her2-<br> | |
| PIK3CA positive: HR- Her2-<br> | |
| PIK3CA positive: HR- Her2+<br> | |
| PIK3CA positive: HR+ Her2+<br> | |
| PIK3CA negative<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with PIK3CA mutations |  | Up to approximately 6 years | 
| Time from first BC diagnosis to first PIK3CA evaluation |  | Up to approximately 6 years | 
| Time from advanced BC diagnosis 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 | 
| Number of tests for patients with CDK4/6 inhibitor treatment |  | Up to approximately 6 years | 
| Time from progression on CDK4/6 inhibitor 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 biopsy |  | 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 | 
| Analytical method used for PIK3CA evaluation |  | Up to approximately 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Performance as assessed by Karnofsky Performace Scale | The Karnofsky Performance Scale is a measure of functional impairment. | Up to approximately 6 years | 
| Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale | 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. | Up to approximately 6 years | 
| Height |  | Up to approximately 6 years | 
| Weight |  | Up to approximately 6 years | 
| Body mass index (BMI) |  | Up to approximately 6 years | 
| Number of patients per stage of cancer |  | 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 treatment sequence |  | Up to approximately 6 years | 
| Number of patients per supportive treatment |  | Up to approximately 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer,, PIK3CA,, Alpelisib,, non-interventional study,, HR+