Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
818actual
Sites
215
Countries
Argentina, Australia, Belgium +16
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-04-16 | actual | When the study began enrolling |
| Primary completion | 2023-05-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-22 | estimated | The whole study's end, after follow-up |
| First posted | 2020-03-12 | actual | When this record first appeared on the registry |
| Results posted | 2025-10-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-04-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Locally Advanced (Inoperable) or Metastatic Breast Cancer
Interventions
- Drug: Fulvestrant
- Drug: Capivasertib
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFProgression Free Survival: Overall Population (Months) in the Global Cohort
measured Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
Progression Free Survival: Overall Population (Percentage) in the Global Cohort
measured Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
Progression Free Survival: Altered Population (Months) in the Global Cohort
measured Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
Progression Free Survival: Altered Population (Percentage) in the Global Cohort
measured Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
Progression Free Survival: Overall Population (Months) in the China Cohort
measured Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
Progression Free Survival: Overall Population (Percentage) in the China Cohort
measured Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
Progression Free Survival: Altered Population (Months) in the China Cohort
measured Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
Progression Free Survival: Altered Population (Percentage) in the China Cohort
measured Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-08-01 · 6.9 MB · Prot_003.pdf
Statistical Analysis Planposted 2022-11-22 · 1.8 MB · SAP_001.pdf
Publications
- PMID 37256976 — cited as background
- PMID 39283299 — linked by the registry
- PMID 39214106 — linked by the registry
- PMID 39159418 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · AZN's whole pipeline · Catalyst calendar · Every registered study · What changed