The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Breast Cancer

Vepdegestrant (ARV-471)*

Vepdegestrant is an investigational compound. Its safety and efficacy have not been established. * Vepdegestrant is being co-developed with Arvinas.

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
Phase 2
NCT05549505

Active Not-enrolling

Globe
Locations

United States, Georgia, Germany, Spain

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Study design

Participant Group/Arm

EXPERIMENTAL: ARV-471 monotherapy

ARV-471 taken once daily until surgical resection

Intervention/Treatment

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)

Participant Group/Arm

ACTIVE_COMPARATOR: Anastrozole monotherapy

Anastrozole 1mg taken once daily until surgical resection

Intervention/Treatment

DRUG: Anastrozole

1mg tablet

PROCEDURE: Surgical resection of breast tumor

Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)

Study design table for Clinical Trial

Key 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 local
  • 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

Key dates

Study start date
  • February 2023
Estimated primary completion date
  • August 2024

Key endpoints

Primary Outcome Measures
Outcome Measure

Evaluate the effects of ARV-471 and anastrozole, respectively, on Ki-67 expression in tumors after 2 weeks of treatment

Measure Description

Percent change in Ki-67 expression between baseline and C1D15 tumor biopsies

Time Frame

2 weeks

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Evaluate the safety/tolerability of ARV-471 and anastrozole, respectively

Measure Description

Incidence of all adverse events, serious adverse events, and adverse events leading to study drug discontinuation

Time Frame

From signing of consent to minimum of 30 days after last administration of study drug

Outcome Measure

Evaluate the pathological response of ARV-471 and anastrozole, respectively (pathologic stage)

Measure Description

Pathologic stage at the time of surgical resection

Time Frame

Approximately 5.5 months

Outcome Measure

Evaluate the pathological response of ARV-471 and anastrozole, respectively (pathologic complete response rate)

Measure Description

pathologic complete response rate at the time of surgical resection

Time Frame

Approximately 5.5 months

Outcome Measure

Evaluate the pathological response of ARV-471 and anastrozole, respectively (modified Pre-operative Endocrine Prognostic Index score)

Measure Description

modified Pre-operative Endocrine Prognostic Index score at the time of surgical resection

Time Frame

Approximately 5.5 months

Outcome Measure

Evaluate the clinical response of ARV-471 and anastrozole, respectively (breast conserving surgery rate)

Measure Description

rates of breast conserving surgery

Time Frame

Approximately 5.5 months

Outcome Measure

Evaluate the clinical response of ARV-471 and anastrozole, respectively (radiographic response)

Measure Description

radiographical response rate in the primary tumor during cycle 6

Time Frame

Approximately 5 months

Outcome Measure

Evaluate the clinical response of ARV-471 and anastrozole, respectively (caliper-based response)

Measure Description

Best percentage change from baseline up to C6D1 in caliper measurement of the primary tumor

Time Frame

Approximately 5 months

Secondary Outcome Measures table for Clinical Trial

Number of participants

152

Collaborators and investigators

Sponsor: Arvinas Inc.

Collaborator: Pfizer

This information is current as of May 7th 2024.
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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT05549505