Clinical trial · Observational
Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (5)
- label
- PIK3CA positive: HR+ Her2-
- label
- PIK3CA positive: HR- Her2-
- label
- PIK3CA positive: HR- Her2+
- label
- PIK3CA positive: HR+ Her2+
- label
- PIK3CA negative
Primary outcomes (12)
- measure
- Number of patients with PIK3CA mutations
- timeFrame
- Up to approximately 6 years
- measure
- Time from first BC diagnosis to first PIK3CA evaluation
- timeFrame
- Up to approximately 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available