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New hope for advanced breast cancer: experimental combo targets resistant tumors

NCT ID NCT06105632

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 2 times

Summary

This phase 2 trial tests a new drug called PF-07220060 combined with fulvestrant against standard treatments in 333 adults with HR-positive, HER2-negative advanced or metastatic breast cancer that has worsened after prior CDK4/6 inhibitor therapy. Half receive the experimental combo, the other half get the doctor's choice of fulvestrant alone or everolimus plus exemestane. The study measures how long the cancer stays under control and overall survival.

What this could mean

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

Active substance
PF-07220060 (a CDK4 inhibitor) plus fulvestrant
What this could lead to
If it works, this could offer a new treatment option for people with advanced breast cancer whose disease has worsened after prior CDK4/6 inhibitor therapy.
What could go wrong
This is a mid-stage trial with 333 participants, so results are not yet proven. The experimental drug may not improve outcomes or could cause side effects that outweigh benefits.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

333 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Jan 2028

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 confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. * Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor * Documented HER2-negative tumor * Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen. * Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment. * Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2. Exclusion Criteria: * Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study. * In visceral crisis at risk of immediately life-threatening complications in the short term. * Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease. * Prior treatment with any of the following: * Everolimus or investigational anti-cancer agents in any setting * Prior chemotherapy in the advanced setting * Radiation within 2 weeks of randomization * Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 \[CYP3A4/5\] or uridine 5' diphosphate-glucuronosyltransferase 2B7 \[UGT2B7\] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors). * Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer Recurrence

As listed by the trial registrant

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

Advanced or metastatic breast cancer

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499, South Korea

  • CIPREC

    Buenos Aires, Buenos Aires F.D., C1061, Argentina

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6, Canada

  • COI Centro Oncologico Internacional S.A.P.I. de C.V.

    Mexico City, Mexico City, 04700, Mexico

  • Centro Para la Atención Integral del Paciente Oncologico (CAIPO)

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Chiba cancer center

    Chiba, 260-8717, Japan

  • Clinica Viedma S. A

    Viedma, Río Negro Province, R8500ACE, Argentina

  • Clínica Universitaria Reina Fabiola

    Córdoba, X5004FHP, Argentina

  • Filios Alta Medicina S.A. de C.V.

    Monterrey, Nuevo León, 64460, Mexico

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 06273, South Korea

  • Gulhane Egitim Arastirma Hastanesi

    Ankara, 06010, Turkey (Türkiye)

  • Gunma Prefectural Cancer Center

    Otashi, Gunma, 373-8550, Japan

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518, Japan

  • 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 São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Icon Cancer Centre Townsville

    Rosslea, Queensland, 4812, Australia

  • Imperial College Healthcare NHS Trust, Charing Cross Hospital

    London, W68RF, United Kingdom

  • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco

    Recife, Pernambuco, 50070-480, Brazil

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851, Mexico

  • Instituto de Oncología de Rosario

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Intermountain Health St. Vincent Regional Hospital

    Billings, Montana, 59101, United States

  • Keck Hospital of USC

    Los Angeles, California, 90033, United States

  • Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medipol Mega Universite Hastanesi

    Stanbul, İ̇stanbul, 34214, Turkey (Türkiye)

  • Memorial Hermann Cancer Center

    Houston, Texas, 77030, United States

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006, Japan

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000, Mexico

  • Osaka University Hospital

    Suita, Osaka, 565-0871, Japan

  • Rajiv Gandhi Cancer Institute And Research Centre

    New Delhi, National Capital Territory of Delhi, 110085, India

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601, Israel

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2, Canada

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra, 411004, India

  • Sarah Cannon Research Institute UK

    London, London, CITY of, w1g 6ad, United Kingdom

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9103102, Israel

  • St. Luke's International Hospital

    Chuo-ku, Tokyo, 104-8560, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Ultramar Medical Imaging Center

    Ankara, 06420, Turkey (Türkiye)

  • Ultramar Medical Imaging Center

    Ankara, 06530, Turkey (Türkiye)

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