Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Estrogens

Mitogens

Anastrozole

Aromatase Inhibitors

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

ARV-471 taken once daily until surgical resection

Anastrozole 1mg taken once daily until surgical resection

ARV-471

Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)

Surgical resection of breast tumor

This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with ER+/HER2- localized breast cancer.

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.

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

Percent change in Ki-67 expression between baseline and C1D15 tumor biopsies

Incidence of all adverse events, serious adverse events, and adverse events leading to study drug discontinuation

Pathologic stage at the time of surgical resection

pathologic complete response rate at the time of surgical resection

modified Pre-operative Endocrine Prognostic Index score at the time of surgical resection

radiographical response rate in the primary tumor during cycle 6

Best percentage change from baseline up to C6D1 in caliper measurement of the primary tumor

Spots Global Cancer Trial Database for untreated breast cancer