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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 1093

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
PIK3CA positive: HR+ Her2-
PIK3CA positive: HR- Her2-
PIK3CA positive: HR- Her2+
PIK3CA positive: HR+ Her2+
PIK3CA negative

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer,; HR+; PIK3CA,; Alpelisib,; non-interventional study,
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CBYL719A0US11