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NCT04305496 · ClinicalTrials.gov registry record · Phase 3
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
A Phase 3 study of Locally Advanced (Inoperable) or Metastatic Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 818
- Enrollment target
- 20
- Study locations
NCT04305496: Active Phase 3 study of Locally Advanced (Inoperable) or Metastatic Breast Cancer, sponsored by AstraZeneca.
NCT04305496 is a Phase 3 study of Locally Advanced (Inoperable) or Metastatic Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 818 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305496, a Phase 3 study of Locally Advanced (Inoperable) or Metastatic Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 818 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause, in the global cohort. Participants who discontinue treatment prior to progression should continue to be scanned until progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (shor
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG Capivasertib
Study Locations (20)
California
- Research Site - Orange
- Research Site - San Francisco
- Research Site - Whittier
Florida
- Research Site - Fort Myers
- Research Site - Jacksonville
Missouri
- Research Site - Kansas City
- Research Site - St Louis
New York
- Research Site - Lake Success
- Research Site - New York
Tennessee
- Research Site - Chattanooga
- Research Site - Nashville
Arizona
- Research Site - Gilbert
Kansas
- Research Site - Westwood
Maryland
- Research Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 818 participants |
| Start Date | 2020-04-16 |
| Est. Completion | 2026-06-22 |
| Phase | Phase 3 |
What the registry record for NCT04305496 still lists
NCT04305496 is an interventional study that assigns participants to a tested intervention. The registered 818 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 1 condition, with Locally Advanced (Inoperable) or Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04305496 names 20 study sites across 14 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT04305496 about?
NCT04305496 is a clinical study titled "Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer". 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.
What is the current status of trial NCT04305496?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 818 participants. The study started on 2020-04-16. Estimated completion is 2026-06-22.
What conditions does trial NCT04305496 study?
This clinical trial studies the following conditions: Locally Advanced (Inoperable) or Metastatic Breast Cancer.
What interventions are being tested in trial NCT04305496?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Capivasertib (DRUG).
Who is sponsoring clinical trial NCT04305496?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305496 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Locally Advanced (Inoperable) or Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04305496's enrollment target sits among peer trials
818 405th of 2000 higher than 1,596 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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