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NCT04214288 · ClinicalTrials.gov registry record · Phase 2

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

A Phase 2 study of Advanced ER-Positive HER2-Negative Breast Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 2
Development phase
240
Enrollment target
20
Study locations

NCT04214288: Active Phase 2 study of Advanced ER-Positive HER2-Negative Breast Cancer, sponsored by AstraZeneca.

NCT04214288 is a Phase 2 study of Advanced ER-Positive HER2-Negative Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 240 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04214288, a Phase 2 study of Advanced ER-Positive HER2-Negative Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
240 participants
Enrollment target
20
Study locations

Study Summary

This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

Primary Outcome

PFS was assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1. PFS was defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or received another anti-cancer therapy prior to progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal

Conditions Studied

Advanced ER-Positive HER2-Negative Breast Cancer

Interventions

  • DRUG Fulvestrant
  • DRUG AZD9833

Study Locations (20)

Other

  • Research Site - Brasschaat
  • Research Site - Charleroi
  • Research Site - Ghent
  • Research Site - Haine-Saint-Paul
  • Research Site - Leuven
  • Research Site - Libramont-Chevigny
  • Research Site - Namur
  • Research Site - Paris

Quebec

  • Research Site - Greenfield Park
  • Research Site - Montreal
  • Research Site - Montreal

Florida

  • Research Site - Fort Myers
  • Research Site - St. Petersburg

Tennessee

  • Research Site - Chattanooga
  • Research Site - Nashville

Alabama

  • Research Site - Birmingham

California

  • Research Site - Long Beach

Nebraska

  • Research Site - Lincoln

Ohio

  • Research Site - Canton

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2020-04-22
Est. Completion 2026-03-17
Phase Phase 2
AstraZeneca

1,285 total trials

What the registry record for NCT04214288 still lists

NCT04214288 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).

The record links to 1 condition, with Advanced ER-Positive HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Fulvestrant is the first listed.

NCT04214288 names 20 study sites across 9 states, led by Other, Quebec, Florida.

Frequently Asked Questions

What is clinical trial NCT04214288 about?

NCT04214288 is a clinical study titled "A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer". This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

What is the current status of trial NCT04214288?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2020-04-22. Estimated completion is 2026-03-17.

What conditions does trial NCT04214288 study?

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

What interventions are being tested in trial NCT04214288?

The interventions under investigation include: Fulvestrant (DRUG), AZD9833 (DRUG).

Who is sponsoring clinical trial NCT04214288?

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

Where is trial NCT04214288 being conducted?

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

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT04214288's enrollment target sits among peer trials

240 239th of 2000 higher than 1,746 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Related registry views

Source: ClinicalTrials.gov NCT04214288, the US trial registry maintained by the National Library of Medicine. NCT04214288 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.