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NCT04546009 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
A Phase 3 study of Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 992
- Enrollment target
- 20
- Study locations
NCT04546009: Active Phase 3 study of Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
NCT04546009 is a Phase 3 study of Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 992 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04546009, a Phase 3 study of Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 992 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Palbociclib
- DRUG Giredestrant
- DRUG Giredestrant-matched Placebo
- DRUG Letrozole-matched Placebo
Study Locations (20)
California
- Orange Coast Memorial Medical Center - Fountain Valley
- Long Beach Memorial Medical Center - Long Beach
- Kaiser Permanente - San Leandro Medical Center - San Leandro
- Stanford Univ Medical Center - Stanford
- Kaiser Permanente - Walnut Creek - Walnut Creek
Florida
- Florida Cancer Specialists - Fort Myers (Broadway) - Fort Myers
- Memorial Regional Cancer Ctr - Hollywood
- University of Miami - Miami
- SCRI Florida Cancer Specialists North - St. Petersburg
- SCRI Florida Cancer Specialists PAN - Tallahassee
Colorado
- University of Colorado - Aurora
- Rocky Mountain Cancer Center - Denver
Maryland
- Mercy Medical Center - Baltimore
- Maryland Oncology Hematology - Silver Spring
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
New Jersey
- Memorial Sloan Kettering Cancer Center Basking Ridge - Basking Ridge
- Astera Cancer Care East Brunswick - East Brunswick
Hawaii
- Kaiser Permanente - Moanalua Medical Center - Honolulu
Missouri
- HCA Midwest Division - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 992 participants |
| Start Date | 2020-10-09 |
| Est. Completion | 2028-03-25 |
| Phase | Phase 3 |
What the registry record for NCT04546009 still lists
NCT04546009 is an interventional study that assigns participants to a tested intervention. The registered 992 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher).
The record links to 1 condition, with Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Letrozole is the first listed.
NCT04546009 names 20 study sites across 8 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04546009 about?
NCT04546009 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)". This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2...
What is the current status of trial NCT04546009?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 992 participants. The study started on 2020-10-09. Estimated completion is 2028-03-25.
What conditions does trial NCT04546009 study?
This clinical trial studies the following conditions: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer.
What interventions are being tested in trial NCT04546009?
The interventions under investigation include: Letrozole (DRUG), Palbociclib (DRUG), Giredestrant (DRUG), Giredestrant-matched Placebo (DRUG), Letrozole-matched Placebo (DRUG).
Who is sponsoring clinical trial NCT04546009?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04546009 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Hawaii, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04546009's enrollment target sits among peer trials
992 314th of 2000 higher than 1,687 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.
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