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Clinical trial

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

NCT05646862 is registered in ClinicalTrials.gov with Hoffmann-La Roche as lead sponsor.

NCT NCT05646862
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy
Lead sponsor
Hoffmann-La Roche
Phase
Phase 3
Overall status
Recruiting
Start date
June 7, 2023
Completion date
March 30, 2029
Enrollment
420 (estimated)
Sites
210

Conditions

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

breast cancer