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New pill combo shows promise for Tough-to-Treat breast cancer

NCT ID NCT06206837

Disease control Sponsor: Pfizer 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests two oral drugs, vepdegestrant and PF-07220060, in people with advanced or metastatic ER+/HER2- breast cancer that has stopped responding to prior treatments. The goal is to see if the combination is safe and can shrink tumors. Participants take the pills at home and visit the clinic every 4 weeks.

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

71 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

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: * Histological or cytological diagnosis of breast cancer. At time of enrollment this must not be amenable to surgical resection with curative intent (≥1% ER+ stained cells as per local practice on the most recent tumor biopsy HER2- tumor by IHC or in-situ hybridization per ASCO/CAP). * prior anticancer therapies: Phase 1b: at least 1 line of SOC for A/MBC; Prior fulvestrant allowed; ≤1 prior chemotherapy line (no antibody-drug conjugates permitted) for A/MBC setting allowed. Phase 2: At least one and maximum 2 lines of ET in A/MBC setting and most recent ET-based regimen for \>6 months. 1, and only 1, prior CDK4/6 inhibitor-based regimen required. Up to 1 prior regimen of cytotoxic chemotherapy (no antibody-drug conjugates permitted) in the A/MBC setting; Prior fulvestrant allowed. * Participant with only non-measurable lesion (Phase1b) or at least 1 measurable lesion as defined by RECIST v1.1. (Phase2) are eligible. * ECOG PS = 0 or 1 (Phase1b) ; ≤2 (Phase2) Exclusion Criteria: * visceral crisis at risk of life-threatening complications in the short term. * Any condition precluding an adeguate absorption of study interventions. * newly diagnosed brain metastases, or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated, clinically stable and discontinued anti-seizure medications and corticosteroids for at least 28 days prior to enrollment in the of study. * history of any other tumor malignancies within the past 3 years, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated in situ carcinoma of the cervix. Inflammatory breast cancer are excluded * impaired cardiovascular function or clinically significant cardiovascular diseases. * concurrent administration of medications, food, or herb supplements that are strong inhibitors/inducers of CYP3A or UGT2B7, moderate inducers of CYP34 (Phase1b only) and drugs known to predispose to Torsade de Pointes or QT interval prolongation. * renal impairment, not adequate liver function and/or bone marrow function. * known active infection

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone 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

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, West-vlaanderen, 8500, Belgium

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650, Belgium

  • BRCR Global - Mayaguez Administrative Office

    Mayagüez, 00680, Puerto Rico

  • BRCR Global - Mayagüez

    Mayagüez, 00682, Puerto Rico

  • Evelyn H. Lauder Breast and Imaging Center (BAIC).

    New York, New York, 10065, United States

  • Highlands Oncology

    Fayetteville, Arkansas, 72703, United States

  • Highlands Oncology

    Rogers, Arkansas, 72758, United States

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Hoag Health Center Irvine

    Irvine, California, 92618, United States

  • Hoag Hospital Irvine

    Irvine, California, 92618, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, Lleida [lérida], 25198, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Institut Jules Bordet

    Anderlecht, Bruxelles-capitale, Région de, 1070, Belgium

  • Institut Paoli-Calmettes

    Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

  • Institut Régional du Cancer Montpellier

    Montpellier, Hérault, 34298, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire-atlantique, 44805, France

  • Kanagawa cancer center

    Yokohama, Kanagawa, 2418515, Japan

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • MSK Bergen

    Montvale, New Jersey, 07645, United States

  • MSK Commack

    Commack, New York, 11725, United States

  • MSK Monmouth

    Middletown, New Jersey, 07748, United States

  • MSK Nassau

    Uniondale, New York, 11553, United States

  • MSK Westchester

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935, Puerto Rico

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rockefeller Outpatient Pavilion (53rd Street)

    New York, New York, 10022, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • START San Antonio

    San Antonio, Texas, 78229, United States

  • Showa Medical University Hospital

    Tokyo, 142-8666, Japan

  • Smilow Cancer Hospital - Trumbull

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital - Yale New Haven Health

    New Haven, Connecticut, 06510, United States

  • Smilow Cancer Hospital Phase 1 Unit

    New Haven, Connecticut, 06511, United States

  • South Jordan Health Center - University of Utah

    South Jordan, Utah, 84106, United States

  • Stanford Cancer Center

    Palo Alto, California, 94304, United States

  • Stanford Cancer Institute - Clinical Trials Office

    Palo Alto, California, 94304, United States

  • Stanford Women's Cancer Center

    Palo Alto, California, 94304, United States

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5, Canada

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • UCHealth - Medical Center of the Rockies

    Loveland, Colorado, 80538, United States

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80634, United States

  • UCHealth Harmony

    Fort Collins, Colorado, 80528, United States

  • UCHealth Poudre Valley Hospital

    Fort Collins, Colorado, 80524, United States

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158, United States

  • UZ Leuven

    Leuven, Vlaams-brabant, 3000, Belgium

  • University of Utah, Farmington Health Center

    Farmington, Utah, 84025, United States

  • University of Utah, Sugar House Health Center

    Salt Lake City, Utah, 84106, United States

  • Wuhan Union Hospital Cancer Center

    Wuhan, Hubei, 430023, China

  • Yale - New Haven Hospital - Yale Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.