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NCT05774951 · ClinicalTrials.gov registry record · Phase 3

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

A Phase 3 study of Breast Cancer, Early Breast Cancer, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 3
Development phase
4,300
Enrollment target
20
Study locations

NCT05774951: Recruiting Phase 3 study of Breast Cancer, Early Breast Cancer, sponsored by AstraZeneca.

NCT05774951 is a Phase 3 study of Breast Cancer, Early Breast Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 4,300 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (457% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05774951, a Phase 3 study of Breast Cancer, Early Breast Cancer, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 3
Development phase
4,300 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

Primary Outcome

IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence (invasive IBTR) * Locoregional invasive breast cancer recurrence * Distant recurrence * Invasive contralateral breast cancer * Death attributable to any cause.

Conditions Studied

Breast Cancer, Early Breast Cancer

Interventions

  • DRUG Camizestrant
  • DRUG Tamoxifen
  • DRUG Anastrozole
  • DRUG Letrozole
  • DRUG Exemestane

Study Locations (20)

California

  • Research Site - Anaheim
  • Research Site - Beverly Hills
  • Research Site - Concord
  • Research Site - Corona
  • Research Site - Fountain Valley
  • Research Site - Greenbrae
  • Research Site - Los Alamitos
  • Research Site - Palo Alto
  • Research Site - San Diego
  • Research Site - San Diego
  • Research Site - Whittier

Alabama

  • Research Site - Birmingham
  • Research Site - Dothan

Florida

  • Research Site - Fort Myers
  • Research Site - Gainesville

Alaska

  • Research Site - Anchorage

Arizona

  • Research Site - Chandler

Arkansas

  • Research Site - Hot Springs

Colorado

  • Research Site - Aurora

Connecticut

  • Research Site - Hartford

Trial Details

FieldValue
Enrollment Target 4,300 participants
Start Date 2023-03-31
Est. Completion 2036-05-29
Phase Phase 3
AstraZeneca

1,285 total trials

What NCT05774951 shows while recruiting

NCT05774951 is an interventional study that assigns participants to a tested intervention. Its 4,300 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (457% higher).

The record links to 1 condition, with Breast Cancer, Early Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Camizestrant is the first listed.

NCT05774951 names 20 study sites across 8 states, led by California, Alabama, Florida.

Frequently Asked Questions

What is clinical trial NCT05774951 about?

NCT05774951 is a clinical study titled "A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy". This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) a...

What is the current status of trial NCT05774951?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 4,300 participants. The study started on 2023-03-31. Estimated completion is 2036-05-29.

What conditions does trial NCT05774951 study?

This clinical trial studies the following conditions: Breast Cancer, Early Breast Cancer.

What interventions are being tested in trial NCT05774951?

The interventions under investigation include: Camizestrant (DRUG), Tamoxifen (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG).

Who is sponsoring clinical trial NCT05774951?

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

Where is trial NCT05774951 being conducted?

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

Learn More About Clinical Trials

Similar trials for Breast Cancer, Early 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 NCT05774951's enrollment target sits among peer trials

4,300 57th of 2000 higher than 1,944 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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More recruiting context for NCT05774951

Source: ClinicalTrials.gov NCT05774951, the US trial registry maintained by the National Library of Medicine. NCT05774951 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.