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 44 sites in 4 countries.
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
- 44 sitesin 4 countries
- Study dates
- 24 Sep 2025to 1 Aug 2030
- Phase
- Phase 2
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
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- 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
44 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
44 sites in 4 countries
United States29 sites, 29 recruiting
- Recruiting
The University of New Mexico
Albuquerque, New Mexico, 87131
- Recruiting
Accellacare of McFarland
Ames, Iowa, 50010
- Recruiting
Hematology Oncology Associates of Central New York
Camillus, New York, 13031
- Recruiting
Levine Cancer
Charlotte, North Carolina, 28204
- 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
University of Wisconsin
Madison, Wisconsin, 53706
- Recruiting
Sarah Cannon Research Institute (Nashville)
Nashville, Tennessee, 37203
- 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
Italy6 sites, 6 recruiting
- 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
Spain6 sites, 5 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 0-8035
- Recruiting
Hospital del Mar
Barcelona, 08003
- Recruiting
Hospital Clinic Barcelona
Barcelona, 08036
- Active, not recruiting
Hospital Universitario San Cecilio
Granada, Andalusia, 18007
- Recruiting
Hosp Beata María Ana de Jesús
Madrid, 28007
- Recruiting
Álvaro Cunqueiro Hospital
Vigo, Galicia, 36312
Germany3 sites, 3 recruiting
- Recruiting
Hämatologie-Onkologie Zentrum
Augsburg, 86150
- Recruiting
Mammazentrum Hamburg MVZ GbR
Hamburg, 20357
- Recruiting
Marien Hospital Witten
Witten, 58452
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
- Conditions
- HER2-positive Breast Cancer, 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 group | Role | What they receive |
|---|---|---|
| Zanidatamab with paclitaxel | Active comparator | Zanidatamab in combination with chemotherapy paclitaxel Receives: Drug: Zanidatamab; Drug: Paclitaxel |
| Zanidatamab with docetaxel and carboplatin | Active comparator | Zanidatamab in combination with chemotherapy docetaxel and carboplatin Receives: Drug: Zanidatamab; Drug: Docetaxel; Drug: Carboplatin |
| Trastuzumab and pertuzumab with docetaxel and carboplatin | Active comparator | Trastuzumab 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.
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)
Number of participants with Pathologic response by Residual Cancer Burden (RCB) classification
Measured: Up to 8 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 23 months
Number of Participants Discontinuing Study Treatment Due to TEAEs
Measured: Up to 23 months
Number of participants that completed breast conservation surgery (BCS)
Measured: Up to 8 months
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
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
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
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
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
Serum Concentrations of Zanidatamab
Measured: Up to 18 months
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.
- First posted3 Aug 2025
- Study start24 Sep 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Ireland Limited
- Responsible party
- Sponsor
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
- Sep 2026
- First submitted
- 28 Jul 2025
- Last updated
- 1 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.