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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

NCT04214288 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-11-20

Study results available
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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.

Conditions

  • Advanced ER-Positive HER2-Negative Breast Cancer

Interventions

DRUG

AZD9833

Dosage formulation: AZD9833 tablets will be administered orally.

DRUG

Fulvestrant

Dosage formulation: Fulvestrant will be administered via intramuscular (IM) injection.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-22
Primary Completion
2022-08-30
Completion
2026-03-17
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04214288 on ClinicalTrials.gov