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

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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