Study on ARV-471 Alone and with Palbociclib for Advanced ER+/HER2- Breast Cancer

Sponsor: Arvinas Estrogen Receptor, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04072952

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, ARV-471, alone and in combination with Palbociclib (IBRANCE®) for patients with advanced breast cancer that is estrogen receptor positive and HER2 negative. Participants should have previously received hormonal therapy and chemotherapy.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective ARV-471 is when used alone or with Palbociclib in treating patients with advanced breast cancer that is ER+ and HER2-. This type of breast cancer has spread beyond the initial site and does not respond to standard treatments. The trial is open to patients who have already tried hormonal and chemotherapy treatments for their advanced cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have confirmed advanced breast cancer that is ER+ and HER2-.
  • Cancer must not be treatable with standard curative therapy.
  • Must have measurable or non-measurable cancer based on specific criteria.
  • Willing to have a tumor biopsy before and during the study.
  • Women must be postmenopausal.

Part A:

  • Must have tried at least two hormone treatments and a CDK4/6 inhibitor, plus up to three chemotherapy treatments for advanced cancer.

Part B:

  • Must have tried at least one hormone treatment for at least six months and a CDK4/6 inhibitor, plus up to one chemotherapy treatment for advanced cancer.

Part C:

  • Must have tried at least one hormone treatment and no more than two chemotherapy treatments for advanced cancer.

Exclusion Criteria

  • Have active brain cancer requiring high-dose steroids. Patients with treated brain cancer can join if they have recovered and are stable without high-dose steroids for at least four weeks.
  • Have received any cancer treatment or experimental therapy within 14 days before starting the study.
  • Have had radiation therapy within four weeks before starting the study, except for pain relief from bone cancer.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.