A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
Public ClinicalTrials.gov record NCT04436744. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Multicenter, Open-Label, Two-Arm, Phase II, Neoadjuvant Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early breast cancer. The study consists of a screening period of up to 28 days, a window-of-opportunity phase for 14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles), surgery, and an end of study visit (28 days after the final dose of study treatment).
Study identification
- NCT ID
- NCT04436744
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 221 participants
Conditions and interventions
Conditions
Interventions
- Giredestrant Drug
- Anastrozole Drug
- Palbociclib Drug
- Surgery Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 3, 2020
- Primary completion
- Jul 5, 2021
- Completion
- Nov 23, 2021
- Last update posted
- Feb 1, 2023
2020 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 5
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA - Burbank | Burbank | California | 91505 | — |
| UCLA - Laguna Hills | Laguna Hills | California | 92653 | — |
| UCLA Hematology/Oncology-San Luis Obispo | San Luis Obispo | California | 93401 | — |
| UCLA Hematology Oncology-Santa Monica | Santa Monica | California | 90404 | — |
| Torrance Memorial Physician Network/Cancer Care | Torrance | California | 90505 | — |
| Orlando Health Inc. | Orlando | Florida | 32806 | — |
| SCRI Florida Cancer Specialists East | West Palm Beach | Florida | 33401 | — |
| Saint Barnabas Medical Center Cancer Center | Livingston | New Jersey | 07039 | — |
| Tennessee Oncology; Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Univ of Wisconsin-Madison; Clinical Science Center | Madison | Wisconsin | 53762 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04436744, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2023 · Synced Sep 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04436744 live on ClinicalTrials.gov.