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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: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT04436744 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 221 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Ki67 is a proliferation biomarker with prognostic value in ER-positive breast cancer. Ki67 scores were centrally assessed with immunohistochemistry and defined as a percentage of positively stained tumor cell nuclei among the total number of tumor cells assessed, with a potential range of 0-100%. A score of 0% indicates no tumor cell nuclei with Ki67 staining and a score of 100% indicates all tumor cell nuclei are positively stained with Ki67. The relative percentage change was calculated using
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 |
What the finished NCT04436744 record still lists
NCT04436744 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% higher).
The record links to 0 conditions, and to 4 interventions - of which Anastrozole is the first listed.
NCT04436744 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04436744's enrollment target sits among peer trials
221 275th of 2000 higher than 1,726 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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