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

NCT05982886 | Completed

• 1 other identifier: CBYL719A0US11
• Study Type: observational
• Target: 1,093
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer,; PIK3CA,; Alpelisib,; non-interventional study,; HR+

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (14)

• 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

  Up to approximately 6 years

• Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale

  Up to approximately 6 years

Study Arms (5)

PIK3CA positive: HR+ Her2-

PIK3CA positive: HR- Her2-

PIK3CA positive: HR- Her2+

PIK3CA positive: HR+ Her2+

PIK3CA negative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: January 15, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 9, 2023

Record last verified: 2023-07

Locations

US (1)