A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
a study on Breast Cancer Menopause HER2
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedcompletion around
Description
Summary
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with ER+/HER2- localized breast cancer.
Official Title
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
Details
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.
Keywords
Breast Cancer, Early breast cancer, Localized breast cancer, Untreated breast cancer, Pre-operative breast cancer, Treatment-naïve breast cancer, Neoadjuvant, Estrogen receptor, Estrogen receptor positive, ER+, Hormone positive, Hormone receptor positive, HR+, human epidermal growth factor receptor 2, HER2-, ARV-471, Anastrozole, Arimidex, Aromatase inhibitor, Vepdegestrant, Breast Neoplasms, Surgical resection of breast tumor, ARV-471 monotherapy, Anastrozole monotherapy
Eligibility
You can join if…
Open to females ages 18 years and up
- 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
You CAN'T join if...
- 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
Locations
- Clinical Trial Site
Los Angeles California 90095 United States - Clinical Trial Site
Van Nuys California 91405 United States - Clinical Trial Site
Torrance California 90505 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Arvinas Inc.
- ID
- NCT05549505
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- About 152 people participating
- Last Updated