Breast Cancer
Conditions
Keywords
Breast cancer,, PIK3CA,, Alpelisib,, non-interventional study,, HR+
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients per treatment sequence | Up to approximately 6 years | — |
| Age at advanced breast cancer diagnosis | Up to approximately 6 years | — |
| Number of patients per supportive treatment | 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 | Up to approximately 6 years | The Karnofsky Performance Scale is a measure of functional impairment. |
| 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. |
| 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 | — |
Countries
United States
Outcome results
None listed