Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This is a first in human, dose escalation study and will assess the safety and tolerability of ARV-471 in woman and men with ER+/HER2- locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.

Official Title

A Phase 1, Open-label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ARV-471 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally Advanced/Metastatic Setting

Keywords

Breast Cancer Metastatic Breast Cancer Malignant Neoplasm of the Breast mBC ER+/HER2- Locally Advanced Breast Cancer Breast Neoplasms ARV-471

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients at least 18 years of age at the time of signing the informed consent.
  • Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer. Advanced breast cancer is metastatic, recurrent, or locally advanced unresectable breast cancer for which standard curative therapy is no longer effective or does not exist.
  • Patients must have measurable or non-measurable disease by RECIST criteria (version1.1), with radiologic tumor assessments performed within 28 days of the first dose of therapy.
  • Patients must have received at least 2 prior endocrine regimens in any setting (neoadjuvant, adjuvant or advanced/metastatic) a CDK4/6 inhibitor and up to 3 prior regimens of cytotoxic chemotherapy in the locally advanced or metastatic setting. All such therapy must be discontinued at least 14 days prior to enrollment.
  • Patients must be willing to undergo a biopsy of accessible tumor within 4 weeks prior to the initiation of study treatment and a follow-up biopsy on treatment for ER IHC testing and PD studies. (Patients without accessible tumor tissue may be eligible after discussion with the Medical Monitor.)

You CAN'T join if...

  • Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses). Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to first dose of study drug, have discontinued high-dose corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable as judged by the Investigator.
  • Patients who have received 4 or more regimens of chemotherapy for locally advanced or mBC.
  • Receipt of prior anti-cancer or other investigational therapy within 14 days prior to the first administration of study drug.
  • Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study.

Locations

  • UCLA Medical Center accepting new patients
    Santa Monica California 90404 United States
  • Sarah Cannon accepting new patients
    Nashville Tennessee 37203 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arvinas Inc
ID
NCT04072952
Phase
Phase 1
Study Type
Interventional
Last Updated