Breast Cancer Clinical Trial

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

Summary

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

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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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

152

Study ID:

NCT05549505

Recruitment Status:

Active, not recruiting

Sponsor:

Arvinas Inc.

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There are 49 Locations for this study

See Locations Near You

Clinical Trial Site
Springdale Arkansas, 72762, United States
Clinical Trial Site
Los Angeles California, 90095, United States
Clinical Trial Site
Torrance California, 90505, United States
Clinical Trial Site
Van Nuys California, 91405, United States
Clinical Trial Site
Fort Lauderdale Florida, 33308, United States
Clinical Trial Site
Fort Myers Florida, 33901, United States
Clinical Trial Site
Orlando Florida, 32806, United States
Clinical Trial Site
West Palm Beach Florida, 33401, United States
Clinical Trial Site
Iowa City Iowa, 52242, United States
Clinical Trial Site
Springfield Massachusetts, 01199, United States
Clinical Trial Site
Saint Louis Missouri, 63110, United States
Clinical Trial Site
Nashville Tennessee, 37203, United States
Clinical Trial Site
Tacoma Washington, 98405, United States
Clinical Trial Site
Batumi , 6000, Georgia
Clinical Trial Site
Tbilisi , 0112, Georgia
Clinical Trial Site
Tbilisi , 0144, Georgia
Clinical Trial Site
Tbilisi , 0159, Georgia
Clinical Trial Site
Augsburg , 86156, Germany
Clinical Trial Site
Berlin , 13125, Germany
Clinical Trial Site
Bonn , 53111, Germany
Clinical Trial Site
Bottrop , 46236, Germany
Clinical Trial Site
Chemnitz , 09116, Germany
Clinical Trial Site
Dresden , 01307, Germany
Clinical Trial Site
Erlangen , 91054, Germany
Clinical Trial Site
Essen , 45113, Germany
Clinical Trial Site
Essen , 45147, Germany
Clinical Trial Site
Esslingen , 73730, Germany
Clinical Trial Site
Mannheim , 68167, Germany
Clinical Trial Site
Paderborn , 33098, Germany
Clinical Trial Site
La Coruna Galicia, 15006, Spain
Clinical Trial Site
San Cristobal de La laguna Santa Cruz De Tenerife, 38320, Spain
Clinical Trial Site
Alicante , 03010, Spain
Clinical Trial Site
Barcelona , 08025, Spain
Clinical Trial Site
Barcelona , 08036, Spain
Clinical Trial Site
Barcelona , 08916, Spain
Clinical Trial Site
Castelló , 12002, Spain
Clinical Trial Site
Córdoba , 14004, Spain
Clinical Trial Site
Granada , 18005, Spain
Clinical Trial Site
Granada , 18014, Spain
Clinical Trial Site
Lleida , 25198, Spain
Clinical Trial Site
Madrid , 28034, Spain
Clinical Trial Site
Madrid , 28040, Spain
Clinical Trial Site
Madrid , 28922, Spain
Clinical Trial Site
Manresa , 08243, Spain
Clinical Trial Site
Sevilla , 41009, Spain
Clinical Trial Site
Sevilla , 41013, Spain
Clinical Trial Site
Valencia , 46009, Spain
Clinical Trial Site
Valencia , 46010, Spain
Clinical Trial Site
Zaragoza , 50009, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

152

Study ID:

NCT05549505

Recruitment Status:

Active, not recruiting

Sponsor:


Arvinas Inc.

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