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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05549505
Recruitment Status : Recruiting
First Posted : September 22, 2022
Last Update Posted : January 27, 2023
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Arvinas Inc.

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ARV-471 Drug: Anastrozole Procedure: Surgical resection of breast tumor Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole

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 ± 10 days)

Active Comparator: Anastrozole monotherapy
Anastrozole 1mg taken once daily until surgical resection
Drug: Anastrozole
1mg tablet
Other Name: Arimidex

Procedure: Surgical resection of breast tumor
Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 10 days)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05549505


Contacts
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Contact: Arvinas Estrogen Receptor, Inc. 475-345-3366 clinicaltrialsARV-471@arvinas.com

Locations
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United States, Missouri
Clinical Trial Site Recruiting
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Arvinas Inc.
Pfizer
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Responsible Party: Arvinas Inc.
ClinicalTrials.gov Identifier: NCT05549505    
Other Study ID Numbers: ARV-471-BC-201
C4891025 ( Other Identifier: Pfizer )
First Posted: September 22, 2022    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arvinas Inc.:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs