Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
NCT ID: NCT05982886
Last Updated: 2023-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1093 participants
OBSERVATIONAL
2021-01-15
2021-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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PIK3CA positive: HR+ Her2-
No interventions assigned to this group
PIK3CA positive: HR- Her2-
No interventions assigned to this group
PIK3CA positive: HR- Her2+
No interventions assigned to this group
PIK3CA positive: HR+ Her2+
No interventions assigned to this group
PIK3CA negative
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis
East Hanover, New Jersey, United States
Countries
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Other Identifiers
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CBYL719A0US11
Identifier Type: -
Identifier Source: org_study_id
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