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NCT05549505 · ClinicalTrials.gov registry record · Phase 2
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
A Phase 2 study, sponsored by Arvinas.
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
NCT05549505: Completed Phase 2 study, sponsored by Arvinas.
NCT05549505 is a Phase 2 study that has completed, run by Arvinas. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05549505, a Phase 2 study, has completed, sponsored by Arvinas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
Study Summary
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
Primary Outcome
Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected. Ki-67 expression was assessed by immunohistochemical staining in a central laboratory. The log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, ba
Interventions
- DRUG Anastrozole
- DRUG ARV-471
- PROCEDURE Surgical resection of breast tumor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2024-07-25 |
| Phase | Phase 2 |
What the finished NCT05549505 record still lists
NCT05549505 is an interventional study that assigns participants to a tested intervention. The registered 152 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 (14% higher).
The record links to 0 conditions, and to 3 interventions - of which Anastrozole is the first listed.
NCT05549505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05549505 about?
NCT05549505 is a clinical study titled "A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery". This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
What is the current status of trial NCT05549505?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2023-02-15. Estimated completion is 2024-07-25.
What interventions are being tested in trial NCT05549505?
The interventions under investigation include: Anastrozole (DRUG), ARV-471 (DRUG), Surgical resection of breast tumor (PROCEDURE).
Who is sponsoring clinical trial NCT05549505?
This trial is sponsored by Arvinas, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05549505's enrollment target sits among peer trials
152 452nd of 2000 higher than 1,547 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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