drugset
drugset / 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

NCT04072952 ↗

Phase 1/2 Completed 219 enrolled Arvinas Estrogen Receptor, Inc. Pfizer · collab
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2019-09-22
Primary completion
2024-09-13
Completion
2026-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Palbociclib Small molecule 100 mg Oral
Subject Palbociclib Small molecule 125 mg Oral
Subject vepdegestrant Other / unclassified 30 mg Oral
Subject vepdegestrant Other / unclassified 60 mg Oral
Subject vepdegestrant Other / unclassified 100 mg Oral
Subject vepdegestrant Other / unclassified 120 mg Oral
Subject vepdegestrant Other / unclassified 180 mg Oral
Subject vepdegestrant Other / unclassified 200 mg Oral
Subject vepdegestrant Other / unclassified 360 mg Oral
Subject vepdegestrant Other / unclassified 400 mg Oral
Subject vepdegestrant Other / unclassified 500 mg Oral
Subject vepdegestrant Other / unclassified 700 mg Oral

Indications

breast cancer