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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982886
• Other study ID #: CBYL719A0US11
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: July 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1093
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with PIK3CA mutations		Up to approximately 6 years
Primary	Time from first BC diagnosis to first PIK3CA evaluation		Up to approximately 6 years
Primary	Time from advanced BC diagnosis to first PIK3CA evaluation		Up to approximately 6 years
Primary	Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation		Up to approximately 6 years
Primary	Number of tests for patients with CDK4/6 inhibitor treatment		Up to approximately 6 years
Primary	Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation		Up to approximately 6 years
Primary	Year of (first, where applicable) PIK3CA evaluation		Up to approximately 6 years
Primary	Result of PIK3CA evaluation (negative, positive, unknown)		Up to approximately 6 years
Primary	Type of biopsy		Up to approximately 6 years
Primary	Type of tissue sample, for patients who had tissue biopsy		Up to approximately 6 years
Primary	Source of tissue sample, for patients who had tissue biopsy		Up to approximately 6 years
Primary	Analytical method used for PIK3CA evaluation		Up to approximately 6 years
Secondary	Age at advanced breast cancer diagnosis		Up to approximately 6 years
Secondary	Stage when patients were diagnosed with BC		Up to approximately 6 years
Secondary	Number of patients with known metastatic sites		Up to approximately 6 years
Secondary	Performance as assessed by Karnofsky Performace Scale	The Karnofsky Performance Scale is a measure of functional impairment.	Up to approximately 6 years
Secondary	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
Secondary	Height		Up to approximately 6 years
Secondary	Weight		Up to approximately 6 years
Secondary	Body mass index (BMI)		Up to approximately 6 years
Secondary	Number of patients per stage of cancer		Up to approximately 6 years
Secondary	Number of patients per line of treatment		Up to approximately 6 years
Secondary	Time from advanced diagnosis to initiation of lines of treatment		Up to approximately 6 years
Secondary	Number of patients per systemic therapy		Up to approximately 6 years
Secondary	Number of patients per treatment sequence		Up to approximately 6 years
Secondary	Number of patients per supportive treatment		Up to approximately 6 years