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New drug duo aims to wipe out breast cancer before surgery

NCT ID NCT07102381

Disease control Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 5 times

Summary

This study tests whether adding zanidatamab to standard chemotherapy can completely eliminate cancer in people with early-stage HER2-positive breast cancer before they have surgery. About 125 participants with stage II or III disease will receive the combination, and doctors will check tissue removed during surgery for any remaining cancer. The goal is to see if this approach is safe and more effective than chemo alone.

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

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2030

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: 1. Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma. 2. Has histologically confirmed HER2-positive breast cancer 3. Has a known hormone receptor (HR) status of the primary tumor 4. Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive. 5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate organ function 8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization. 9. Adequate contraceptive precautions 10. Participants with known HIV are eligible unless: 1. CD4+ T Cell count is less than or equal to 350 microliters (uL) 2. Detectable viral load, or 3. Receiving protease inhibitors or cobicistat Exclusion Criteria: 1. Has Stage IV (metastatic) breast cancer. 2. Has bilateral breast cancer. 3. Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study. 4. Has uncontrolled hypertension 5. Has significant symptoms from peripheral neuropathy 6. Has an active uncontrolled infection 7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions. 8. Known active hepatitis B or C infection. 9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible. 10. Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer 11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol 12. Receipt of a live vaccine within 4 weeks prior to enrollment 13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer HER2-positive breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accellacare of McFarland

    RECRUITING

    Ames, Iowa, 50010, United States

  • Astera Cancer Care (Formerly Regional Cancer Care Associates)

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Cancer & Blood Research Center

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Cancer Partners of Nebraska

    RECRUITING

    Lincoln, Nebraska, 68516, United States

  • Hematology Oncology Associates of Central New York

    RECRUITING

    Camillus, New York, 13031, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Holy Cross Hospital

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Hosp Beata María Ana de Jesús

    ACTIVE_NOT_RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario San Cecilio

    ACTIVE_NOT_RECRUITING

    Granada, Andalusia, 18007, Spain

  • Hospital Universitario Vall d'Hebron

    ACTIVE_NOT_RECRUITING

    Barcelona, 0-8035, Spain

  • Istituto Europeo di Oncologia

    ACTIVE_NOT_RECRUITING

    Milan, 20141, Italy

  • LSU Health Sciences Center

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Levine Cancer

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Maryland Oncology Hematology

    RECRUITING

    Laurel, Maryland, 20707, United States

  • Medical Oncology Hematology Associates

    RECRUITING

    Newark, New Jersey, 19713, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68124, United States

  • New England Cancer Specialists

    RECRUITING

    Scarborough, Maine, 04074, United States

  • Northwest Cancer Specialists

    RECRUITING

    Vancouver, Washington, 98648, United States

  • Northwest Medical Specialties

    RECRUITING

    Puyallup, Washington, 98373, United States

  • Oncology Institute

    RECRUITING

    Long Beach, California, 90805, United States

  • Ospedale San Raffaele

    ACTIVE_NOT_RECRUITING

    Milan, Lombardy, 20132, Italy

  • Rocky Mountain Cancer Centers

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute (Nashville)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Shenandoah Oncology

    RECRUITING

    Winchester, Virginia, 22601, United States

  • Texas Oncology DFW

    RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology Gulf Coast

    RECRUITING

    Houston, Texas, 77024, United States

  • The Oncology Institute

    RECRUITING

    Lakeland, Florida, 33812, United States

  • The University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • The University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • UT Health San Antonio, Mays Cancer Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53706, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Álvaro Cunqueiro Hospital

    ACTIVE_NOT_RECRUITING

    Vigo, Galicia, 36312, Spain

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