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HER2-positive Breast CancerPhase 2EmpowHER 208NCT07102381

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

A Phase 2 study testing Zanidatamab, Paclitaxel and Docetaxel in people with HER2-positive Breast Cancer and Breast Cancer, run by Jazz Pharmaceuticals at 53 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Breast Cancer, Breast Cancer
What is being tested?
Zanidatamab, Paclitaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
53 sitesin 4 countries
Study dates
24 Sep 2025to 2 May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.
  • Has histologically confirmed HER2-positive breast cancer
  • Has a known hormone receptor (HR) status of the primary tumor
  • 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.
  • Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Adequate organ function
  • Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.
  • Adequate contraceptive precautions
  • Participants with known HIV are eligible unless:
  • CD4+ T Cell count is less than or equal to 350 microliters (uL)
  • Detectable viral load, or
  • Receiving protease inhibitors or cobicistat

Who cannot join

  • Has Stage IV (metastatic) breast cancer.
  • Has bilateral breast cancer.
  • 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.
  • Has uncontrolled hypertension
  • Has significant symptoms from peripheral neuropathy
  • Has an active uncontrolled infection
Show all 13Show fewer
  • 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.
  • Known active hepatitis B or C infection.
  • 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.
  • Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
  • Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
  • Receipt of a live vaccine within 4 weeks prior to enrollment
  • Has a known hypersensitivity to any components of the study interventions, including chemotherapy

Trial locations and contacts

53 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trial Disclosure & Transparency contact

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

53 sites in 4 countries

United States34 sites, 34 recruiting

  • The University of New Mexico

    Albuquerque, New Mexico, 87131

    Recruiting

  • Accellacare of McFarland

    Ames, Iowa, 50010

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Hematology Oncology Associates of Central New York

    Camillus, New York, 13031

    Recruiting

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Levine Cancer

    Charlotte, North Carolina, 28204

    Recruiting

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637-1470

    Recruiting

  • Texas Oncology DFW

    Dallas, Texas, 75246

    Recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Recruiting

  • Astera Cancer Care (Formerly Regional Cancer Care Associates)

    East Brunswick, New Jersey, 08816

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Recruiting

  • Texas Oncology Gulf Coast

    Houston, Texas, 77024

    Recruiting

  • The Oncology Institute

    Lakeland, Florida, 33812

    Recruiting

  • Maryland Oncology Hematology

    Laurel, Maryland, 20707

    Recruiting

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

    Recruiting

  • Oncology Institute

    Long Beach, California, 90805

    Recruiting

  • Cancer & Blood Research Center

    Los Alamitos, California, 90720

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53706

    Recruiting

  • Sarah Cannon Research Institute (Nashville)

    Nashville, Tennessee, 37203

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Medical Oncology Hematology Associates

    Newark, New Jersey, 19713

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68124

    Recruiting

  • Northwest Medical Specialties

    Puyallup, Washington, 98373

    Recruiting

  • UT Health San Antonio, Mays Cancer Center

    San Antonio, Texas, 78229

    Recruiting

  • New England Cancer Specialists

    Scarborough, Maine, 04074

    Recruiting

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71103

    Recruiting

  • Northwest Cancer Specialists

    Vancouver, Washington, 98648

    Recruiting

  • Shenandoah Oncology

    Winchester, Virginia, 22601

    Recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 0-8035

    Recruiting

  • Hospital del Mar

    Barcelona, 08003

    Recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario San Cecilio

    Granada, Andalusia, 18007

    Recruiting

  • Hosp Beata María Ana de Jesús

    Madrid, 28007

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

    Recruiting

  • Álvaro Cunqueiro Hospital

    Vigo, Galicia, 36312

    Recruiting

Other trials in Spain

Italy6 sites, 6 recruiting

  • AOU di Bologna

    Bologna, 40138

    Recruiting

  • Policlinico San Martino

    Genoa, 16132

    Recruiting

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Humanitas Ist.Clinico Catanese

    Misterbianco, 95045

    Recruiting

  • IRCCS San Gerardo dei Tintori

    Monza, 20900

    Recruiting

Other trials in Italy

Germany5 sites, 5 recruiting

  • Hämatologie-Onkologie Zentrum

    Augsburg, 86150

    Recruiting

  • Mammazentrum Hamburg MVZ GbR

    Hamburg, 20357

    Recruiting

  • Institut Fuer Versorgungsforschung In Der Onkologie GbR

    Koblenz, 56068

    Recruiting

  • Marien Hospital Witten

    Witten, 58452

    Recruiting

  • Klinikum Worms gGmbH

    Worms, 67550

    Recruiting

Other trials in Germany

About this study

Official title: A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer

Being tested
Zanidatamab, Paclitaxel, Docetaxel, Carboplatin, Trastuzumab
Keywords
HER2-positive early breast cancer, invasive breast carcinoma, zanidatamab, breast neoplasm
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanidatamabDrug

    Also called ZW25, JZP598, ZIIHERA®

    Administered intravenously (IV)

  • PaclitaxelDrug

    Administered intravenously (IV)

  • DocetaxelDrug

    Administered intravenously (IV)

  • CarboplatinDrug

    Administered intravenously (IV)

  • TrastuzumabDrug

    Administered intravenously (IV)

  • PertuzumabDrug

    Administered intravenously (IV)

Study groups in NCT07102381
Study groupRoleWhat they receive
Zanidatamab with paclitaxelActive comparatorZanidatamab in combination with chemotherapy paclitaxel
Receives: Drug: Zanidatamab; Drug: Paclitaxel
Zanidatamab with docetaxel and carboplatinActive comparatorZanidatamab in combination with chemotherapy docetaxel and carboplatin
Receives: Drug: Zanidatamab; Drug: Docetaxel; Drug: Carboplatin
Trastuzumab and pertuzumab with docetaxel and carboplatinActive comparatorTrastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin
Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with pCR

    Pathologic complete response (pCR) is defined as lacking all signs of cancer in the tissue samples removed in the breast or axilla (armpit) during surgery or biopsy after study treatment

    Measured: Up to 8 months

Secondary outcomes (11)

  1. Number of participants with Pathologic response by Residual Cancer Burden (RCB) classification

    Measured: Up to 8 months

  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to 23 months

  3. Number of Participants Discontinuing Study Treatment Due to TEAEs

    Measured: Up to 23 months

  4. Number of participants that completed breast conservation surgery (BCS)

    Measured: Up to 8 months

  5. Event Free Survival (EFS)

    EFS is defined as the time (in months) from randomization to disease progression, disease recurrence, second primary invasive cancer (non-breast) or death from any cause

    Measured: Up to 46 months

  6. Overall Survival (OS)

    OS is defined as the time in months from randomization to the date of death due to any cause.

    Measured: Up to 46 months

  7. Number of participants reporting Symptomatic Adverse Events based on Patient-reported Outcome-Common Terminology Criteria for AEs (PRO-CTCAE)

    Symptomatic AEs assessed by the PRO-CTCAE are analyzed at the item level with symptom severity, frequency, and interference scored from 0 to 4 and presence/absence scored 0 to 1, and higher scores reflect worse symptoms.

    Measured: Up to 23 months

  8. Number of participants reporting Symptomatic Adverse Events based on European Organisation for Research and Treatment of Cancer (EORTC) Item Library

    Symptomatic AEs assessed by the EORTC Item Library Forms are analyzed at the item level with scores ranging from 1 to 4, where a 4 indicates more severe symptoms.

    Measured: Up to 23 months

  9. Percentage of all treated participants reporting overall side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5)

    The Functional Assessment of Chronic Illness Therapy (FACIT) GP5 Item score ranges from 0 (Not at all) to 4 (Very Much), where higher scores reflect greater bother from treatment side effects.

    Measured: Up to 23 months

  10. Serum Concentrations of Zanidatamab

    Measured: Up to 18 months

  11. Number of Participants Positive for Anti-drug Antibodies to Zanidatamab

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start24 Sep 2025
  3. Primary completion29 Dec 2027 (estimated)
  4. Study completion2 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07102381
Sponsor's protocol ID
JZP598-208
Other IDs
2025-523204-68-00, 2025
Acronym
EmpowHER 208
Status last verified
Oct 2026
First submitted
28 Jul 2025
Last updated
29 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanidatamab, Paclitaxel and Docetaxel in people with HER2-positive Breast Cancer and Breast Cancer, run by Jazz Pharmaceuticals at 53 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Spain, Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with pCR (time frame: Up to 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07102381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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