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

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Arvinas

Status and phase

Active, not recruiting
Phase 2

Conditions

Breast Cancer

Treatments

Drug: ARV-471
Drug: Anastrozole
Procedure: Surgical resection of breast tumor

Study type

Interventional

Funder types

Industry

Identifiers

NCT05549505
C4891025 (Other Identifier)
ARV-471-BC-201

Details and patient eligibility

About

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

Full 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.

Enrollment

152 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

152 participants in 2 patient groups

ARV-471 monotherapy
Experimental group
Description:
ARV-471 taken once daily until surgical resection
Treatment:
Procedure: Surgical resection of breast tumor
Drug: ARV-471
Anastrozole monotherapy
Active Comparator group
Description:
Anastrozole 1mg taken once daily until surgical resection
Treatment:
Procedure: Surgical resection of breast tumor
Drug: Anastrozole

Trial contacts and locations

49

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Central trial contact

Arvinas Estrogen Receptor, Inc.

Data sourced from clinicaltrials.gov

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