Clinical Trial: NCT04305496
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-04-30 |
Study Overview
Brief Summary
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.
Official Title
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor
Conditions
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Intervention / Treatment
- Drug: Fulvestrant
- Drug: Capivasertib
- Drug: Placebo
Other Study ID Numbers
- D3615C00001
- 2023-505042-25-00
- 2019-003629-78
- 2019
- 2023
Start Date (Actual)
2020-04-16
Primary Completion Date (Actual)
2023-05-09
Study Completion Date (Estimated)
2026-06-22
Enrollment (Actual)
818
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-04-30 |
Study Overview
Brief Summary
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.
Official Title
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor
Conditions
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Intervention / Treatment
- Drug: Fulvestrant
- Drug: Capivasertib
- Drug: Placebo
Other Study ID Numbers
- D3615C00001
- 2023-505042-25-00
- 2019-003629-78
- 2019
- 2023
Start Date (Actual)
2020-04-16
Primary Completion Date (Actual)
2023-05-09
Study Completion Date (Estimated)
2026-06-22
Enrollment (Actual)
818
Study Type
Interventional
Phase
Phase 3