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Active, not recruiting Phase 3 Interventional Results available

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

ClinicalTrials.gov ID: NCT04305496

Public ClinicalTrials.gov record NCT04305496. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04305496
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
818 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 130 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 16, 2020 (Actual)
Primary completion
May 9, 2023 (Actual)
Completion
Jun 22, 2026 (Estimated)
Last update posted
Apr 30, 2026

2020 – 2026

United States locations

U.S. sites
22
U.S. states
16
U.S. cities
22
Facility City State ZIP Site status
Research Site Gilbert Arizona 85234 —
Research Site Orange California 92868 —
Research Site San Francisco California 94143 —
Research Site Whittier California 90603 —
Research Site Fort Myers Florida 33905 —
Research Site Jacksonville Florida 32224 —
Research Site Westwood Kansas 66205 —
Research Site Baltimore Maryland 21201 —
Research Site Boston Massachusetts 02111-1520 —
Research Site Rochester Minnesota 55905 —
Research Site Kansas City Missouri 64132 —
Research Site St Louis Missouri 63156 —
Research Site Paramus New Jersey 07652 —
Research Site Farmington New Mexico 87401 —
Research Site Lake Success New York 11042 —
Research Site New York New York 10011 —
Research Site Greensboro North Carolina 27403 —
Research Site Chattanooga Tennessee 37404 —
Research Site Nashville Tennessee 37211 —
Research Site Dallas Texas 75246 —
Research Site Midlothian Virginia 23114 —
Research Site Puyallup Washington 98373 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 193 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04305496, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 30, 2026 · Synced Oct 17, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04305496 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →