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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 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. The trial reports 20 study locations across 14 states.

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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.

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

FieldValue
Enrollment Target 818 participants
Start Date 2020-04-16
Est. Completion 2026-06-22
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT04305496

The ClinicalTrials.gov registry entry for NCT04305496 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 818 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.