A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
NCT ID: NCT05549505
Last Updated: 2025-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2023-02-15
2024-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: ARV-471 (Experimental)
Participants received 200 mg ARV-471 (2\*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than Cycle 6 Day 18 \[C6D18\] + 14 days).
ARV-471
100 mg tablet
Surgical resection of breast tumor
Surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)
Arm B: Anastrozole
Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).
Anastrozole
1 mg tablet
Surgical resection of breast tumor
Surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)
Interventions
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ARV-471
100 mg tablet
Anastrozole
1 mg tablet
Surgical resection of breast tumor
Surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 immunohistochemistry (IHC) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
* 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.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection.
Exclusion Criteria
* 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).
* corrected QT (Fridericia method) (QTcF) \> 470 msec.
* Active, uncontrolled bacterial, fungal or viral infection, including (but not limited to) hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (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.
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Arvinas Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Springdale, Arkansas, United States
Clinical Trial Site
Los Angeles, California, United States
Clinical Trial Site
Torrance, California, United States
Clinical Trial Site
Van Nuys, California, United States
Clinical Trial Site
Fort Lauderdale, Florida, United States
Clinical Trial Site
Fort Myers, Florida, United States
Clinical Trial Site
Orlando, Florida, United States
Clinical Trial Site
West Palm Beach, Florida, United States
Clinical Trial Site
Iowa City, Iowa, United States
Clinical Trial Site
Springfield, Massachusetts, United States
Clinical Trial Site
St Louis, Missouri, United States
Clinical Trial Site
Nashville, Tennessee, United States
Clinical Trial Site
Tacoma, Washington, United States
Clinical Trial Site
Batumi, , Georgia
Clinical Trial Site
Tbilisi, , Georgia
Clinical Trial Site
Tbilisi, , Georgia
Clinical Trial Site
Tbilisi, , Georgia
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 am Neckar, , Germany
Clinical Trial Site
Mannheim, , Germany
Clinical Trial Site
Paderborn, , Germany
Clinical Trial Site
A Coruña, Galicia, Spain
Clinical Trial Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 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
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
Seville, , Spain
Clinical Trial Site
Seville, , Spain
Clinical Trial Site
Valencia, , Spain
Clinical Trial Site
Valencia, , Spain
Clinical Trial Site
Zaragoza, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C4891025
Identifier Type: OTHER
Identifier Source: secondary_id
ARV-471-BC-201
Identifier Type: -
Identifier Source: org_study_id
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