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NCT06065748 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,050
- Enrollment target
- 20
- Study locations
NCT06065748: Recruiting Phase 3 study of Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer, sponsored by Hoffmann-La Roche.
NCT06065748 is a Phase 3 study of Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 1,050 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06065748, a Phase 3 study of Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,050 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Abemaciclib
- DRUG Ribociclib
- DRUG Giredestrant
Study Locations (20)
California
- Sutter Auburn Faith Hospital - Auburn
- La Hematology Oncology Medical Group - Glendale
- Marin Cancer Care Inc - Greenbrae
- Kaiser Permanente - Harbor City - Harbor City
- USC Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Cancer Center - Newport Beach
- Sutter Medical Group, Roseville Clinic - Roseville
- Sutter Health Medical Center - Sacramento
- The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente - Torrance
Florida
- AdventHealth Altamonte - Altamonte Springs
- Florida Cancer Specialists - Broadway - Fort Myers
- Cancer Specialists of North Florida - Jacksonville
- Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg) - St. Petersburg
- Comprehensive Hematology Oncology - St. Petersburg
- Florida Cancer Specialists - EAST - SCRI - PPDS - West Palm Beach
District of Columbia
- Georgetown University Medical Center - Washington D.C.
- MedStar Washington Hosp Center - Washington D.C.
Alabama
- Southern Cancer Center - Daphne
Colorado
- Rocky Mountain Cancer Centers - Littleton
Georgia
- Grady Health System - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,050 participants |
| Start Date | 2023-12-11 |
| Est. Completion | 2029-02-12 |
| Phase | Phase 3 |
What NCT06065748 shows while recruiting
NCT06065748 is an interventional study that assigns participants to a tested intervention. Its 1,050 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher).
The record links to 1 condition, with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.
NCT06065748 names 20 study sites across 6 states, led by California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06065748 about?
NCT06065748 is a clinical study titled "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)". 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 recepto...
What is the current status of trial NCT06065748?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,050 participants. The study started on 2023-12-11. Estimated completion is 2029-02-12.
What conditions does trial NCT06065748 study?
This clinical trial studies the following conditions: Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer.
What interventions are being tested in trial NCT06065748?
The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), Giredestrant (DRUG).
Who is sponsoring clinical trial NCT06065748?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06065748 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06065748's enrollment target sits among peer trials
1,050 282nd of 2000 higher than 1,719 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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