NCT05549505Phase 2Completed

A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-07-13Actual

Enrollment · participants152Actual

Source updated2025-08-29Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Breast Cancer

Treatments or interventions studied

ARV-471DrugAlso known as Vepdegestrant, PF-07850327
AnastrozoleDrugAlso known as Arimidex

Primary outcomes · main study measures

Read the study measures

measure: Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies; description: 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, baseline Ki-67 score and the tumor size) and treatment as co-variates. The treatment effects were back transformed into geometric means and their Confidence Intervals. The percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1 - geometric mean ratio between Ki-67 at C1D15 and Ki-67 at baseline).; timeFrame: Baseline (during screening, prior to Day 1) and Day 15

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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