A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT06065748
Trial Phases:	Phase III	Protocol IDs:	CO44657 (primary) NCI-2024-00434 2022-502980-39-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hoffmann-La Roche
NCI Full Details:	http://clinicaltrials.gov/show/NCT06065748

Summary

This is a Phase III, randomized, open-label multicenter study that will evaluate the
efficacy and safety of giredestrant compared with fulvestrant, both in combination with
the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib),
in participants with estrogen receptor-positive (ER+), human epidermal growth factor
receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to
adjuvant endocrine therapy.

Treatment Sites in Georgia

Georgia Cancer Center for Excellence at Grady
80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
404-489-9000
www.gradyhealth.org

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

**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.