Clinical Trial: NCT02437318
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2025-02-13 |
Study Overview
Brief Summary
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.
Official Title
Conditions
Intervention / Treatment
- Drug: Fulvestrant
- Drug: Alpelisib
- Drug: Placebo
Other Study ID Numbers
- CBYL719C2301
- 2015-000340-42
- 2015
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2025-02-13 |
Study Overview
Brief Summary
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.
Official Title
Conditions
Intervention / Treatment
- Drug: Fulvestrant
- Drug: Alpelisib
- Drug: Placebo
Other Study ID Numbers
- CBYL719C2301
- 2015-000340-42
- 2015