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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05549505
Other study ID # ARV-471-BC-201
Secondary ID C4891025
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 15, 2023
Est. completion date August 15, 2024

Study information

Verified date January 2024
Source Arvinas Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 152
Est. completion date August 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
ARV-471
tablets
Anastrozole
1mg tablet
Procedure:
Surgical resection of breast tumor
Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)

Locations

Country Name City State
Georgia Clinical Trial Site Batumi
Georgia Clinical Trial Site Tbilisi
Georgia Clinical Trial Site Tbilisi
Georgia Clinical Trial Site Tbilisi
Germany Clinical Trial Site Augsburg
Germany Clinical Trial Site Berlin
Germany Clinical Trial Site Bonn
Germany Clinical Trial Site Bottrop
Germany Clinical Trial Site Chemnitz
Germany Clinical Trial Site Dresden
Germany Clinical Trial Site Erlangen
Germany Clinical Trial Site Essen
Germany Clinical Trial Site Essen
Germany Clinical Trial Site Esslingen
Germany Clinical Trial Site Mannheim
Germany Clinical Trial Site Paderborn
Spain Clinical Trial Site Alicante
Spain Clinical Trial Site Barcelona
Spain Clinical Trial Site Barcelona
Spain Clinical Trial Site Barcelona
Spain Clinical Trial Site Castelló
Spain Clinical Trial Site Córdoba
Spain Clinical Trial Site Granada
Spain Clinical Trial Site Granada
Spain Clinical Trial Site La Coruna Galicia
Spain Clinical Trial Site Lleida
Spain Clinical Trial Site Madrid
Spain Clinical Trial Site Madrid
Spain Clinical Trial Site Madrid
Spain Clinical Trial Site Manresa
Spain Clinical Trial Site San Cristobal de La laguna Santa Cruz De Tenerife
Spain Clinical Trial Site Sevilla
Spain Clinical Trial Site Sevilla
Spain Clinical Trial Site Valencia
Spain Clinical Trial Site Valencia
Spain Clinical Trial Site Zaragoza
United States Clinical Trial Site Fort Lauderdale Florida
United States Clinical Trial Site Fort Myers Florida
United States Clinical Trial Site Iowa City Iowa
United States Clinical Trial Site Los Angeles California
United States Clinical Trial Site Nashville Tennessee
United States Clinical Trial Site Orlando Florida
United States Clinical Trial Site Saint Louis Missouri
United States Clinical Trial Site Springdale Arkansas
United States Clinical Trial Site Springfield Massachusetts
United States Clinical Trial Site Tacoma Washington
United States Clinical Trial Site Torrance California
United States Clinical Trial Site Van Nuys California
United States Clinical Trial Site West Palm Beach Florida

Sponsors (2)

Lead Sponsor Collaborator
Arvinas Inc. Pfizer

Countries where clinical trial is conducted

United States,  Georgia,  Germany,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the effects of ARV-471 and anastrozole, respectively, on Ki-67 expression in tumors after 2 weeks of treatment Percent change in Ki-67 expression between baseline and C1D15 tumor biopsies 2 weeks
Secondary Evaluate the safety/tolerability of ARV-471 and anastrozole, respectively Incidence of all adverse events, serious adverse events, and adverse events leading to study drug discontinuation From signing of consent to minimum of 30 days after last administration of study drug
Secondary Evaluate the pathological response of ARV-471 and anastrozole, respectively (pathologic stage) Pathologic stage at the time of surgical resection Approximately 5.5 months
Secondary Evaluate the pathological response of ARV-471 and anastrozole, respectively (pathologic complete response rate) pathologic complete response rate at the time of surgical resection Approximately 5.5 months
Secondary Evaluate the pathological response of ARV-471 and anastrozole, respectively (modified Pre-operative Endocrine Prognostic Index score) modified Pre-operative Endocrine Prognostic Index score at the time of surgical resection Approximately 5.5 months
Secondary Evaluate the clinical response of ARV-471 and anastrozole, respectively (breast conserving surgery rate) rates of breast conserving surgery Approximately 5.5 months
Secondary Evaluate the clinical response of ARV-471 and anastrozole, respectively (radiographic response) radiographical response rate in the primary tumor during cycle 6 Approximately 5 months
Secondary Evaluate the clinical response of ARV-471 and anastrozole, respectively (caliper-based response) Best percentage change from baseline up to C6D1 in caliper measurement of the primary tumor Approximately 5 months
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