NCT05549505

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

An Open-label, Randomized, Non-comparative Phase 2 Study of ARV-471 or Anastrozole in Post-menopausal Women With ER+/HER2- Breast Cancer in the Neoadjuvant Setting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Arvinas Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, open-label, randomized, non-comparative proof of concept study of ARV-471 or anastrozole in participants with ER+/HER2- breast cancer amenable to definitive surgical resection. The main goal of this study is to evaluate the biological activity of ARV-471 and anastrozole, respectively.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	ARV-471	100 mg tablet
DRUG	Anastrozole	1 mg tablet
PROCEDURE	Surgical resection of breast tumor	Surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)

Timeline

• Start date: 2023-02-15
• Primary completion: 2024-07-13
• Completion: 2024-07-25
• First posted: 2022-09-22
• Last updated: 2025-08-29
• Results posted: 2025-08-29

Locations

49 sites across 4 countries: United States, Georgia, Germany, Spain

Regulatory

• FDA-regulated drug study