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New pill combo shows promise in shrinking breast tumors before surgery

NCT ID NCT06465368

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This phase 2 trial tested whether adding the experimental drug PF-07220060 to the standard hormone therapy letrozole works better than letrozole alone in postmenopausal women with a common type of breast cancer (HR+/HER2-). The 121 participants took the pills for 14 days before their planned surgery. Researchers measured tumor cell changes through biopsies to see if the combination slows cancer growth more effectively.

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 plus letrozole
What this could lead to
If successful, this combination could shrink tumors before surgery, potentially improving outcomes for women with HR+/HER2- breast cancer.
What could go wrong
This is a small, early-phase trial with only 121 participants and a short 14-day treatment period. Results may not lead to a new standard of care, and side effects are still being evaluated.

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

121 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 2025

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

Female participants only

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: * Postmenopausal women with histologically confirmed HR-positive and HER2-negative BC (per local assessment) * Documented by estrogen receptor (ER) and/or progesterone receptor (PR)-positive disease by IHC or ISH * Participants must have Ki-67 score \>/=10% with unilateral, invasive T1c-T4c, N0-N2, M0 BC * Participants must be willing and able to undergo a baseline and Day 14 biopsy and must have an ECOG PS or 0 or 1. * Participants must be treatment naive for the treatment of BC and cannot have had prior treatment with any systemic therapy (e.g., chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents or use of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogen) within 2 weeks prior to diagnostic tissue sample taken. Exclusion Criteria: * No prior systemic therapy, radiation, surgery, investigational therapy for treatment of breast cancer * Certain medical conditions in the previous 6 months, for example: myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism or other clinically significant episode of thromboembolism * Lab abnormalities outside protocol specified parameters

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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

  • AIDPORT Sp. z o.o.

    Skórzewo, Greater Poland Voivodeship, 60-185, Poland

  • AMG -Crystal Lake

    Crystal Lake, Illinois, 60014, United States

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010, United States

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Advocate Medical Group

    Park Ridge, Illinois, 60068, United States

  • Akademiska sjukhuset

    Uppsala, Uppsala LÄN [se-03], 751 85, Sweden

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100, Italy

  • Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno

    Livorno, Tuscany, 57124, Italy

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030, United States

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030, United States

  • Ben Taub General Hospital

    Houston, Texas, 77030, United States

  • CHU de Saint-Etienne

    Saint Priest En Jarez, Pays de la Loire Region, 42271, France

  • CaritasKlinikum Saarbrücken St. Theresia

    Saarbrücken, Saarland, 66113, Germany

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer

    Rennes, Ille-et-vilaine, 35042, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhône, 69310, France

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, Languedoc-roussillon, 34070, France

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy, 20900, Italy

  • Gustave Roussy

    Villejuif, Val-de-marne, 94800, France

  • HCL, Centre Hospitalier Lyon Sud

    Saint-Genis-Laval, Rhône, 69230, France

  • Harris Health System - Smith Clinic

    Houston, Texas, 77054, United States

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, Región de, 30120, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203, Spain

  • Hospital Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario San Cecilio

    Granada, 18016, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [cataluña], 08041, Spain

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna, 47014, Italy

  • Institut Jules Bordet

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

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire-atlantique, 44805, France

  • Kantonsspital Baden

    Baden, 5404, Switzerland

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Narodny onkologicky ustav

    Bratislava, 833 10, Slovakia

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • Nemocnica AGEL Komarno

    Komárno, Nitra Region, 945 05, Slovakia

  • O'Quinn Medical Tower - McNair Campus

    Houston, Texas, 77054, United States

  • Ospedale Antonio Perrino

    Brindisi, 72100, Italy

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Royal Melbourne Hospital

    Parkville, Victoria, 3052, Australia

  • START San Antonio

    San Antonio, Texas, 78229, United States

  • Seoul National University Hospital

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

  • Sjukhuset I Gävle

    Gävle, Gävleborgs LÄN [se-21], 80187, Sweden

  • Tumor Zentrum Aarau

    Aarau, Canton of Aargau, 5000, Switzerland

  • UZ Leuven

    Leuven, Vlaams-brabant, 3000, Belgium

  • University Hospital Basel

    Basel, Canton of Basel-City, 4031, Switzerland

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

    Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

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