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

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05646862
Trial Phases:	Phase III	Protocol IDs:	WO43919 (primary) NCI-2023-01628 2022-502322-41-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hoffmann-La Roche
NCI Full Details:	http://clinicaltrials.gov/show/NCT05646862

Summary

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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