A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT06790693
Trial Phases:	Phase III	Protocol IDs:	WO45654 (primary) NCI-2025-02679 2024-516162-11-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hoffmann-La Roche
NCI Full Details:	http://clinicaltrials.gov/show/NCT06790693

Summary

This study will evaluate the efficacy and safety of the combination of inavolisib plus a
cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a
CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive
PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2-), advanced breast cancer (ABC).

Treatment Sites in Georgia

Northwest Georgia Oncology Centers (NGOC)
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 3060

Study Coordinator:

Kristine Parker
470-267-1480

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.