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


Brief Summary

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

Primary Purpose
Study Type
Phase 2


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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:
    • ER+ disease, with ER staining of ≥ 10% of tumor cell nuclei by IHC per ASCO/CAP Guidelines (Allison 2020).
    • HER2- disease by either IHC or in situ hybridization per ASCO/CAP guidelines
    • Ki-67 score ≥ 5%, analyzed locally
  • 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:

  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ
  • Any of the following in the previous 6 months: Myocardial infarction; Severe unstable angina; Coronary/peripheral artery bypass graft; Symptomatic congestive heart failure (New York Heart Association class III or IV); Cerebrovascular accident; Transient ischemic attack; Symptomatic pulmonary embolism or other clinically significant episode of thromboembolism
  • Any of the following in the previous 6 months: Congenital long QT syndrome; Torsade de Pointes; Sustained ventricular tachyarrhythmia and ventricular fibrillation; Left anterior hemiblock (bifascicular block); Ongoing cardiac dysrhythmias of NCI CTCAE ≥ Grade 2; Atrial fibrillation of any grade (≥ Grade 2 in the case of asymptomatic lone atrial fibrillation)
  • QTcF > 470 msec
  • Active, uncontrolled bacterial, fungal or viral infection, including HBV, HCV, and HIV or AIDS-related illness
  • Active inflammatory gastrointestinal disease, chronic diarrhea, known uncontrolled diverticular disease, or previous gastric resection or lap band surgery
  • Cirrhosis meeting criteria for Child Pugh B and C
  • Prior treatment for breast cancer including systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents
  • Any live vaccines within 14 days of planned start of first dose of study drug.
  • Major surgery (as defined by the Investigator) within four weeks of first dose of study drug

Join this Trial

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Study Stats
Protocol No.
Monica Rocha
  • TRIO-US - Orlando FL
  • TRIO-US - Redondo Beach
  • TRIO-US - Van Nuys
For Providers
For detailed technical eligibility, visit ClinicalTrials.gov.