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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)

StatusRecruiting
PhasePhase 3
Started2023-12-11
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 48 times since 2023-09-26; most recent filed 2026-08-03. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-08-03
Amendment Study Status, Contacts/Locations v48
2026-07-02
Amendment Study Status, Contacts/Locations v47
2026-06-03
Amendment Study Status, Contacts/Locations, References v46
2026-05-04
Amendment Study Status, Contacts/Locations v45
2026-04-03
Amendment Study Status, Contacts/Locations v44
2026-03-06
Amendment Study Status, Contacts/Locations v43
2026-02-06
Amendment Study Status, Contacts/Locations v42
2026-01-09
Amendment Study Status, Contacts/Locations v41
2025-12-12
Amendment Study Status, Contacts/Locations v40
2025-11-14
Amendment Study Status, Contacts/Locations v39
2025-10-16
Amendment Study Status, Contacts/Locations v38
2025-09-18
Amendment Study Status, Contacts/Locations v37
2025-08-21
Amendment Study Status, Contacts/Locations v36
2025-07-24
Amendment Study Status, Contacts/Locations v35
2025-06-27
Amendment Study Status, Contacts/Locations v34
2025-05-30
Amendment Study Status, Contacts/Locations v33
2025-05-02
Amendment Study Status, Contacts/Locations v32
2025-04-03
Amendment Study Status, Contacts/Locations v31
2025-03-06
Amendment Study Status, Contacts/Locations v30
2025-02-04
Amendment Study Status, Eligibility, Contacts/Locations v29
2025-01-31
Amendment Study Status, Eligibility, Contacts/Locations v28
2025-01-10
Amendment Study Status, Contacts/Locations v27
2024-12-12
Amendment Study Status v26
2024-11-13
Amendment Study Status, Eligibility v25
2024-10-18
Amendment Study Status, Contacts/Locations v24
2024-09-20
Amendment Study Status, Contacts/Locations v23
2024-08-22
Amendment Study Status, Contacts/Locations v22
2024-08-07
Amendment Study Status, Eligibility, Contacts/Locations v21
2024-07-30
Amendment Study Status, Contacts/Locations v20
2024-07-12
Amendment Study Status, Contacts/Locations v19
2024-06-17
Amendment Study Status, Contacts/Locations, IPDSharing v18
2024-05-24
Amendment Study Status, Contacts/Locations v17
2024-05-13
Amendment Study Status, Contacts/Locations v16
2024-04-24
Amendment Study Status, Contacts/Locations v15
2024-04-10
Amendment Study Status, Contacts/Locations v14
2024-03-28
Amendment Study Status, Contacts/Locations v13
2024-03-18
Amendment Study Status, Contacts/Locations v12
2024-03-08
Amendment Study Status, Contacts/Locations v11
2024-03-01
Amendment Study Status, Contacts/Locations v10
2024-02-23
Amendment Study Status, Contacts/Locations v9
2024-02-16
Amendment Study Status, Contacts/Locations v8
2024-02-09
Amendment Study Status, Contacts/Locations v7
2024-02-02
Amendment Study Status, Contacts/Locations v6
2024-01-26
Amendment Study Status, Contacts/Locations v5
2024-01-03
Amendment Study Status, Contacts/Locations v4
2023-12-04
Amendment Study Status, Contacts/Locations v3
2023-11-06
Amendment Study Status, Contacts/Locations v2
2023-10-26
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2023-09-26
Original filing
Trial Details
NCT Number NCT06065748
Lead Sponsor Hoffmann-La Roche
Conditions Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Enrollment 1,050 participants
Start Date 2023-12-11
Primary Completion 2027-02-19 (estimated)
Study Completion 2029-02-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-03