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NCT04072952 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer, sponsored by Arvinas Estrogen Receptor.

Active
Registry status
Phase 1
Development phase
217
Enrollment target
16
Study locations

NCT04072952: Active Phase 1 study of Breast Cancer, sponsored by Arvinas Estrogen Receptor.

NCT04072952 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Arvinas Estrogen Receptor. The registered enrollment target is 217 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04072952, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Arvinas Estrogen Receptor.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
217 participants
Enrollment target
16
Study locations

Study Summary

This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and anti-tumor activity 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.

Primary Outcome

First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug

Conditions Studied

Interventions

  • DRUG ARV-471
  • DRUG ARV-471 in combination with palbociclib (IBRANCE®)

Study Locations (16)

California

  • Clinical Trial Site - Palo Alto
  • Clinical Trial Site - San Francisco
  • Clinical Trial Site - Santa Monica

Florida

  • Clinical Trial Site - Fort Myers
  • Clinical Trial Site - Tampa

Massachusetts

  • Clinical Trial Site - Boston
  • Clinical Trial Site - Boston

Connecticut

  • Clinical Trial Site - Norwalk

Illinois

  • Clinical Trial Site - Chicago

Michigan

  • Clinical Trial Site - Ann Arbor

Missouri

  • Clinical Trial Site - St Louis

New Jersey

  • Clinical Trial Site - East Brunswick

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2019-08-05
Est. Completion 2026-02-27
Phase Phase 1
Arvinas Estrogen Receptor

2 total trials

What the registry record for NCT04072952 still lists

NCT04072952 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which ARV-471 is the first listed.

NCT04072952 lists 16 locations in 12 states (California, Florida, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT04072952 about?

NCT04072952 is a clinical study titled "A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer". This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and anti-tumor activity 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-) lo...

What is the current status of trial NCT04072952?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 217 participants. The study started on 2019-08-05. Estimated completion is 2026-02-27.

What conditions does trial NCT04072952 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT04072952?

The interventions under investigation include: ARV-471 (DRUG), ARV-471 in combination with palbociclib (IBRANCE®) (DRUG).

Who is sponsoring clinical trial NCT04072952?

This trial is sponsored by Arvinas Estrogen Receptor, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04072952 being conducted?

This trial has 16 study locations across California, Connecticut, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04072952's enrollment target sits among peer trials

217 346th of 1224 higher than 878 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04072952, the US trial registry maintained by the National Library of Medicine. NCT04072952 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.