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NCT04711252 · ClinicalTrials.gov registry record · Phase 3

A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

A Phase 3 study of ER-Positive HER2-Negative Breast Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
1,370
Enrollment target
20
Study locations

NCT04711252 is a Phase 3 study of ER-Positive HER2-Negative Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,370 participants. The trial reports 20 study locations across 16 states.

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The verdict

NCT04711252, a Phase 3 study of ER-Positive HER2-Negative Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,370 participants
Enrollment target
20
Study locations

Study Summary

The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.

Interventions

  • DRUG Anastrozole
  • DRUG Palbociclib
  • DRUG AZD9833
  • DRUG Anastrozole placebo
  • DRUG AZD9833 placebo

Study Locations (20)

Florida

  • Research Site - Fort Myers
  • Research Site - Jacksonville
  • Research Site - West Palm Beach

California

  • Research Site - Harbor City
  • Research Site - Solvang

Ohio

  • Research Site - Cincinnati
  • Research Site - Cincinnati

Alabama

  • Research Site - Mobile

Arkansas

  • Research Site - Springdale

Colorado

  • Research Site - Lone Tree

Indiana

  • Research Site - Indianapolis

Louisiana

  • Research Site - Baton Rouge

Trial Details

FieldValue
Enrollment Target 1,370 participants
Start Date 2021-01-28
Est. Completion 2029-02-01
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT04711252

The ClinicalTrials.gov registry entry for NCT04711252 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,370 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 ER-Positive HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Anastrozole is the first listed.

NCT04711252 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Florida, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT04711252 about?

NCT04711252 is a clinical study titled "A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease". The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-nega...

What is the current status of trial NCT04711252?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,370 participants. The study started on 2021-01-28. Estimated completion is 2029-02-01.

What conditions does trial NCT04711252 study?

This clinical trial studies the following conditions: ER-Positive HER2-Negative Breast Cancer.

What interventions are being tested in trial NCT04711252?

The interventions under investigation include: Anastrozole (DRUG), Palbociclib (DRUG), AZD9833 (DRUG), Anastrozole placebo (DRUG), AZD9833 placebo (DRUG).

Who is sponsoring clinical trial NCT04711252?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04711252 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for ER-Positive HER2-Negative Breast Cancer

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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.