Clinical trial NCT05982886: Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
Official title: Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer,
PIK3CA,
Alpelisib,
non-interventional study,
HR+
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-08-09
Enrollment: 1093
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

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.


Eligibility criteria: 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

Primary outcomes:
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
measure: Time from advanced BC diagnosis to first PIK3CA evaluation
timeFrame: Up to approximately 6 years
measure: Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation
timeFrame: Up to approximately 6 years
measure: Number of tests for patients with CDK4/6 inhibitor treatment
timeFrame: Up to approximately 6 years
measure: Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation
timeFrame: Up to approximately 6 years
measure: Year of (first, where applicable) PIK3CA evaluation
timeFrame: Up to approximately 6 years
measure: Result of PIK3CA evaluation (negative, positive, unknown)
timeFrame: Up to approximately 6 years
measure: Type of biopsy
timeFrame: Up to approximately 6 years
measure: Type of tissue sample, for patients who had tissue biopsy
timeFrame: Up to approximately 6 years
measure: Source of tissue sample, for patients who had tissue biopsy
timeFrame: Up to approximately 6 years
measure: Analytical method used for PIK3CA evaluation
timeFrame: Up to approximately 6 years
Secondary outcomes:
measure: Age at advanced breast cancer diagnosis
timeFrame: Up to approximately 6 years
measure: Stage when patients were diagnosed with BC
timeFrame: Up to approximately 6 years
measure: Number of patients with known metastatic sites
timeFrame: Up to approximately 6 years
measure: Performance as assessed by Karnofsky Performace Scale
timeFrame: Up to approximately 6 years
measure: Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
timeFrame: Up to approximately 6 years
measure: Height
timeFrame: Up to approximately 6 years
measure: Weight
timeFrame: Up to approximately 6 years
measure: Body mass index (BMI)
timeFrame: Up to approximately 6 years
measure: Number of patients per stage of cancer
timeFrame: Up to approximately 6 years
measure: Number of patients per line of treatment
timeFrame: Up to approximately 6 years
measure: Time from advanced diagnosis to initiation of lines of treatment
timeFrame: Up to approximately 6 years
measure: Number of patients per systemic therapy
timeFrame: Up to approximately 6 years
measure: Number of patients per treatment sequence
timeFrame: Up to approximately 6 years
measure: Number of patients per supportive treatment
timeFrame: Up to approximately 6 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: