Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
Phase 4
Completed
NCT05631795
| Condition | Advanced Breast Cancer |
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| Phase | Phase 4 |
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| Sponsor | Novartis Pharmaceuticals |
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| Status | Completed |
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| Enrollment | 40 participants |
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| Interventions | Alpelisib, Fulvestrant |
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| Start date | Aug 9, 2022 |
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| Completion date | Jun 12, 2025 |
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| Results posted | Jun 25, 2026 |
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Summary
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer (aBC) with a PIK3CA mutation, whose disease had progressed on or after endocrine-based treatment.
Percentage of Participants With at Least One On-treatment Adverse Events (AEs)
From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months · Percentage of participants
| Alpelisib + Fulvestrant | 100 Percentage of participants |
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Open in BENITIONS
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