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New hope for Hard-to-Treat breast cancer: experimental drug ARV-471 shows promise

NCT ID NCT04072952

Disease control Sponsor: Arvinas Estrogen Receptor, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests an experimental drug called ARV-471, alone or with another drug (palbociclib), in 217 people with advanced ER+/HER2- breast cancer that has stopped responding to standard treatments. The goal is to see if it is safe and can shrink tumors or slow the disease. The study is completed, but results are not yet widely available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARV-471 (a drug that breaks down estrogen receptors) and palbociclib (a targeted cancer drug)
What this could lead to
If it works, this could offer a new treatment option for people with advanced ER+/HER2- breast cancer who have run out of standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. Side effects or lack of benefit could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

217 people

The number who actually took part.

Started

Aug 2019

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Part A, Part B, and Part C: * 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 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 be willing to undergo a core biopsy of accessible tumor within 4 weeks prior to the initiation of study treatment and a follow-up biopsy on treatment for ER immunohistochemistry (IHC) testing and pharmacodynamics (PD) studies. (Patients without accessible tumor tissue may be eligible after discussion with the Medical Monitor.) * Women must be postmenopausal due to surgical or natural menopause. Part A: \- 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. Part B: * Patients must have received at least 1 prior endocrine regimen for a minimum of 6 months in the locally advanced or metastatic setting; if more than 1 prior endocrine regimen has been administered, only one of the regimens must have been administered for a minimum of 6 months in the locally advanced or metastatic setting * Patients must have received a CDK4/6 inhibitor * Patients must have received up to 1 prior regimen of cytotoxic chemotherapy in the locally advanced or metastatic setting * Women must be postmenopausal due to surgical or natural menopause. Part C: * Patients must have received at least one prior endocrine regimen. * Patients must have received no more than two prior chemotherapy regimens for advanced disease. * Women must be postmenopausal due to surgical or natural menopause. Exclusion Criteria: Part A, Part B, and Part C: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Clinical Trial Site

    Palo Alto, California, 94304, United States

  • Clinical Trial Site

    San Francisco, California, 94158, United States

  • Clinical Trial Site

    Santa Monica, California, 90404, United States

  • Clinical Trial Site

    Norwalk, Connecticut, 06856, United States

  • Clinical Trial Site

    Fort Myers, Florida, 33901, United States

  • Clinical Trial Site

    Tampa, Florida, 33612, United States

  • Clinical Trial Site

    Chicago, Illinois, 60637, United States

  • Clinical Trial Site

    Boston, Massachusetts, 02114, United States

  • Clinical Trial Site

    Boston, Massachusetts, 02215, United States

  • Clinical Trial Site

    Ann Arbor, Michigan, 48109, United States

  • Clinical Trial Site

    St Louis, Missouri, 63110, United States

  • Clinical Trial Site

    East Brunswick, New Jersey, 08816, United States

  • Clinical Trial Site

    The Bronx, New York, 10461, United States

  • Clinical Trial Site

    Charlotte, North Carolina, 28204, United States

  • Clinical Trial Site

    Nashville, Tennessee, 37203, United States

  • Clinical Trial Site

    Seattle, Washington, 98109, United States

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