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

January 19, 2024 updated by: Arvinas Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Georgia
      • Batumi, Georgia, 6000
        • Clinical Trial Site
      • Tbilisi, Georgia, 0112
        • Clinical Trial Site
      • Tbilisi, Georgia, 0144
        • Clinical Trial Site
      • Tbilisi, Georgia, 0159
        • Clinical Trial Site
  • Germany
      • Augsburg, Germany, 86156
        • Clinical Trial Site
      • Berlin, Germany, 13125
        • Clinical Trial Site
      • Bonn, Germany, 53111
        • Clinical Trial Site
      • Bottrop, Germany, 46236
        • Clinical Trial Site
      • Chemnitz, Germany, 09116
        • Clinical Trial Site
      • Dresden, Germany, 01307
        • Clinical Trial Site
      • Erlangen, Germany, 91054
        • Clinical Trial Site
      • Essen, Germany, 45147
        • Clinical Trial Site
      • Essen, Germany, 451136
        • Clinical Trial Site
      • Esslingen, Germany, 73730
        • Clinical Trial Site
      • Mannheim, Germany, 68167
        • Clinical Trial Site
      • Paderborn, Germany, 33098
        • Clinical Trial Site
  • Spain
      • Alicante, Spain, 03010
        • Clinical Trial Site
      • Barcelona, Spain, 08036
        • Clinical Trial Site
      • Barcelona, Spain, 08025
        • Clinical Trial Site
      • Barcelona, Spain, 08916
        • Clinical Trial Site
      • Castelló, Spain, 12002
        • Clinical Trial Site
      • Córdoba, Spain, 14004
        • Clinical Trial Site
      • Granada, Spain, 18014
        • Clinical Trial Site
      • Granada, Spain, 18005
        • Clinical Trial Site
      • Lleida, Spain, 25198
        • Clinical Trial Site
      • Madrid, Spain, 28040
        • Clinical Trial Site
      • Madrid, Spain, 28034
        • Clinical Trial Site
      • Madrid, Spain, 28922
        • Clinical Trial Site
      • Manresa, Spain, 08243
        • Clinical Trial Site
      • Sevilla, Spain, 41013
        • Clinical Trial Site
      • Sevilla, Spain, 41009
        • Clinical Trial Site
      • Valencia, Spain, 46009
        • Clinical Trial Site
      • Valencia, Spain, 46010
        • Clinical Trial Site
      • Zaragoza, Spain, 50009
        • Clinical Trial Site
    • Galicia
      • La Coruna, Galicia, Spain, 15006
        • Clinical Trial Site
    • Santa Cruz De Tenerife
      • San Cristobal de La laguna, Santa Cruz De Tenerife, Spain, 38320
        • Clinical Trial Site
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Clinical Trial Site
    • California
      • Los Angeles, California, United States, 90095
        • Clinical Trial Site
      • Torrance, California, United States, 90505
        • Clinical Trial Site
      • Van Nuys, California, United States, 91405
        • Clinical Trial Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Clinical Trial Site
      • Fort Myers, Florida, United States, 33901
        • Clinical Trial Site
      • Orlando, Florida, United States, 32806
        • Clinical Trial Site
      • West Palm Beach, Florida, United States, 33401
        • Clinical Trial Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Clinical Trial Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Clinical Trial Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Clinical Trial Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Trial Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARV-471 monotherapy
ARV-471 taken once daily until surgical resection
Drug: ARV-471
tablets
Procedure: Surgical resection of breast tumor
Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)
Active Comparator: Anastrozole monotherapy
Anastrozole 1mg taken once daily until surgical resection
Drug: Anastrozole
1mg tablet
Other Names:
  • Arimidex
Procedure: Surgical resection of breast tumor
Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effects of ARV-471 and anastrozole, respectively, on Ki-67 expression in tumors after 2 weeks of treatment
Time Frame: 2 weeks
Percent change in Ki-67 expression between baseline and C1D15 tumor biopsies
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety/tolerability of ARV-471 and anastrozole, respectively
Time Frame: From signing of consent to minimum of 30 days after last administration of study drug
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
Evaluate the pathological response of ARV-471 and anastrozole, respectively (pathologic stage)
Time Frame: Approximately 5.5 months
Pathologic stage at the time of surgical resection
Approximately 5.5 months
Evaluate the pathological response of ARV-471 and anastrozole, respectively (pathologic complete response rate)
Time Frame: Approximately 5.5 months
pathologic complete response rate at the time of surgical resection
Approximately 5.5 months
Evaluate the pathological response of ARV-471 and anastrozole, respectively (modified Pre-operative Endocrine Prognostic Index score)
Time Frame: Approximately 5.5 months
modified Pre-operative Endocrine Prognostic Index score at the time of surgical resection
Approximately 5.5 months
Evaluate the clinical response of ARV-471 and anastrozole, respectively (breast conserving surgery rate)
Time Frame: Approximately 5.5 months
rates of breast conserving surgery
Approximately 5.5 months
Evaluate the clinical response of ARV-471 and anastrozole, respectively (radiographic response)
Time Frame: Approximately 5 months
radiographical response rate in the primary tumor during cycle 6
Approximately 5 months
Evaluate the clinical response of ARV-471 and anastrozole, respectively (caliper-based response)
Time Frame: Approximately 5 months
Best percentage change from baseline up to C6D1 in caliper measurement of the primary tumor
Approximately 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arvinas Inc.

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARV-471-BC-201
  • C4891025 (Other Identifier: Pfizer)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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