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Clinical trial

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

NCT04964934 is registered in ClinicalTrials.gov with AstraZeneca as lead sponsor.

NCT NCT04964934
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study
Lead sponsor
AstraZeneca
Phase
Phase 3
Overall status
Active, not recruiting
Start date
June 30, 2021
Completion date
September 1, 2028
Enrollment
315 (actual)
Sites
264

Conditions

As the registry lists them; a condition with its own page is linked.

er-positive her2-negative breast cancer