BENITIONSClinical Trial Intelligence

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

Фаза 4 Завершено NCT05631795

ЗаболеваниеAdvanced Breast Cancer
ФазаФаза 4
СпонсорNovartis Pharmaceuticals
СтатусЗавершено
Участники40 участн.
ВмешательствоAlpelisib, Fulvestrant
Дата начала9.08.2022
Дата завершения12.06.2025
Публикация результатов25.06.2026

Кратко

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 + Fulvestrant100 Percentage of participants

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