OncRef

Clinical Trial: NCT04072952

A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Participants With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Arvinas Estrogen Receptor, Inc.
Information Provided By:Arvinas Inc.
Last Update Posted:2026-09-29

Study Overview

Brief Summary

This was a Phase 1/2 dose escalation and cohort expansion study and assessed the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE®) in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or mBC, who had received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.

Official Title

A Phase 1/2, Open Label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) 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

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Vepdegestrant
  • Drug: Vepdegestrant
  • Drug: Palbociclib

Other Study ID Numbers

  • ARV-471-mBC-101
  • C4891019

Start Date (Actual)

2019-09-22

Primary Completion Date (Actual)

2024-09-13

Study Completion Date (Actual)

2026-03-05

Enrollment (Actual)

219

Study Type

Interventional

Phase

Phase 1, Phase 2