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A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
About
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
Eligibility
Gender
Healthy Volunteers
Minimum Age
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
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Study Stats
Protocol No.
22-001410
Category
Breast Cancer
Principal Investigator
Contact
Location
- TRIO-US - Orlando FL
- TRIO-US - Van Nuys
- UCLA Burbank
- UCLA Laguna Hills
- UCLA Parkside
- UCLA San Luis Obispo
- UCLA Santa Monica
- UCLA Westlake Village
- UCLA Westwood