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NCT04436744 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 221
- Enrollment target
NCT04436744 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 221 participants.
The verdict
NCT04436744, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 221 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Anastrozole
- DRUG Palbociclib
- PROCEDURE Surgery
- DRUG Giredestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2020-09-04 |
| Est. Completion | 2021-11-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04436744
The ClinicalTrials.gov registry entry for NCT04436744 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Anastrozole is the first listed.
NCT04436744 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04436744 about?
NCT04436744 is a clinical study titled "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)". 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...
What is the current status of trial NCT04436744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 221 participants. The study started on 2020-09-04. Estimated completion is 2021-11-24.
What interventions are being tested in trial NCT04436744?
The interventions under investigation include: Anastrozole (DRUG), Palbociclib (DRUG), Surgery (PROCEDURE), Giredestrant (DRUG).
Who is sponsoring clinical trial NCT04436744?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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