Status and phase
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Study type
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About
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with ER+/HER2- localized breast cancer.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Post-menopausal females ≥ 18 years
Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment). ER and HER2 status must be documented:
Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer
The primary tumor must be at least 1.5 cm by imaging
ECOG performance status of 0 or 1 Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
152 participants in 2 patient groups
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Central trial contact
Arvinas Estrogen Receptor, Inc.
Data sourced from clinicaltrials.gov
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