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)

Last updated:
2026-08-15
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View trial details

Overview

Official protocol title:

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2- NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY

Intervention/treatment:
GIREDESTRANT (GDC-9545, RO7197597)/ FULVESTRANT/ PALBOCICLIB/ RIBOCICLIB/ ABEMACICLIB
Medical condition:
BREAST CANCER
Protocol code:
CO44657
Control number:
278010
Status:
Recruiting
Approved:
September 01, 2023
Trial phase:
Phase 3
For more information:
ClinicalTrials.gov - NCT06065748
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: ALL
Age
18 Years and older
Accepts healthy volunteers: No

Contacts and locations

Contact
Name
Reference Study ID Number: CO44657 https://forpatients.roche.com/ No attachments to email below.
Role
CONTACT
Phone:
888-662-6728 (U.S. Only)
Name
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Role
CONTACT
Sponsor
HOFFMANN-LA ROCHE LIMITED

Locations

Alberta

Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Active, not recruiting

Ontario

Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, L5M 2N1
Active, not recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Active, not recruiting
North York General Hospital
Toronto, Ontario, M2K 1E1
Active, not recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Active, not recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Active, not recruiting
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Active, not recruiting

Quebec

Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C2
Active, not recruiting
Centre hospitalier regional de Trois-Rivieres
Trois-Rivières, Quebec, G8Z 3R9
Active, not recruiting
CHU de Québec - Hôpital du Saint-Sacrement
Québec, Quebec, G1S 4L8
Active, not recruiting
CISSS Chaudière-Appalaches
Lévis, Quebec, G6V 3Z1
Active, not recruiting
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
Chicoutimi, Quebec, G7H 5H6
Active, not recruiting
Hopital regional de saint jerome
Saint-Jérôme, Quebec, J7Z 5T3
COMPLETED
McGill University Health Centre - Glen Site
Montreal, Quebec, H4A 3J1
WITHDRAWN

Saskatchewan

Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Active, not recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, SK S7N 4H4
Active, not recruiting
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