A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Active:	No
Cancer Type:	Breast Cancer	NCT ID:	NCT04191499
Trial Phases:	Phase II Phase III	Protocol IDs:	WO41554 (primary) NCI-2020-02312 2019-002455-42
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hoffmann-La Roche
NCI Full Details:	http://clinicaltrials.gov/show/NCT04191499

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in
combination with palbociclib and fulvestrant compared with placebo plus palbociclib and
fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive,
HER2-negative locally advanced or metastatic breast cancer whose disease progressed
during treatment or within 12 months of completing adjuvant endocrine therapy and who
have not received prior systemic therapy for metastatic disease.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD

Aron E. Kefela MD

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica
157 Clinic Avenue
Suite 101 and Suite 102
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Randall E. Pierce MD

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