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New pill shows promise in shrinking breast cancer before surgery

NCT ID NCT04647487

Disease control Sponsor: Eli Lilly and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested a new drug called LY3484356 in 87 postmenopausal women with early-stage, hormone-receptor-positive breast cancer. The goal was to see if the drug is safe and how it affects cancer cells before the participants had surgery. The study lasted up to 2.5 months and measured changes in estrogen receptor levels and cancer cell growth.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

87 people

The number who actually took part.

Started

Apr 2021

Finished

Nov 2022

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: * Have histologically confirmed invasive ER+, HER2- breast carcinoma * Be willing and able to provide pre- and on-treatment tumor samples * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale * Have adequate organ function * Be able to swallow capsules * Be a postmenopausal woman Exclusion Criteria: * Have bilateral invasive breast cancer * Have metastatic breast cancer * Plan to receive concurrent neoadjuvant therapy with any other non-protocol anti-cancer therapy * Have had prior therapy (of any kind) for an invasive or non-invasive breast cancer * Have had prior radiotherapy to the ipsilateral chest wall for any malignancy * Have had prior anti-estrogen therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer * Have had prior hormone-replacement therapy within 4 weeks of the start of study treatment * Have had major surgery within 28 days prior to randomization to allow for post-operative healing of the surgical wound and site(s) * Have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled * Have another serious medical condition * Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years

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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

  • Barts Cancer Institute

    London, London City, EC1A 7BE, United Kingdom

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Helios Kliniken Schwerin

    Schwerin, Mecklenburg-Vorpommern, 19049, Germany

  • Hospital Clinic I Provincial

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050, Spain

  • Hôpital René Huguenin

    Saint-Cloud, Hauts-de-Seine, 92210, France

  • Institut Jules Bordet

    Brussel - Capital, 1070, Belgium

  • Klinikum der Universitaet Muenchen

    München, 80336, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Northwestern Memorial Hosptial

    Chicago, Illinois, 60611, United States

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203, United States

  • The Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Winship Cancer Center Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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