A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121)
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.
Study Type : Interventional (Clinical Trial)- Estimated Enrollment : 400 participants
- Allocation : Randomized
- Intervention Model : Parallel Assignment
- Masking : None (Open Label)
- Primary Purpose : Treatment
- Official 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
- Actual Study Start Date : June 7, 2023
- Estimated Primary Completion Date : March 30, 2029
- Estimated Study Completion Date : March 30, 2029
ClinicalTrials.gov Identifier: NCT05646862
Sponsor: Hoffmann-La Roche
Information provided by (Responsible Party): Hoffmann-La Roche
View this trial on clinicaltrials.gov.
What is a Clinical Trial?
A clinical trial is required by the FDA for any new therapy to come to market. It involves recruiting volunteers to help prove the therapy actually works. Every pill that you take or procedure that is performed by physicians has went through a clinical trial