A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
EmpowHER 208
A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
2 other identifiers
interventional
125
3 countries
26
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2025
Longer than P75 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
September 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
April 29, 2026
April 1, 2026
2.3 years
July 28, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Up to 8 months
Secondary Outcomes (11)
Number of participants with Pathologic response by Residual Cancer Burden (RCB) classification
Up to 8 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Up to 23 months
Number of Participants Discontinuing Study Treatment Due to TEAEs
Up to 23 months
Number of participants that completed breast conservation surgery (BCS)
Up to 8 months
Event Free Survival (EFS)
Up to 46 months
- +6 more secondary outcomes
Study Arms (3)
Zanidatamab with paclitaxel
ACTIVE COMPARATORZanidatamab in combination with chemotherapy paclitaxel
Zanidatamab with docetaxel and carboplatin
ACTIVE COMPARATORZanidatamab in combination with chemotherapy docetaxel and carboplatin
Trastuzumab and pertuzumab with docetaxel and carboplatin
ACTIVE COMPARATORTrastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin
Interventions
Administered intravenously (IV)
Administered intravenously (IV)
Administered intravenously (IV)
Administered intravenously (IV)
Administered intravenously (IV)
Eligibility Criteria
You may qualify if:
- Has 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.
- Adequate organ function
- Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 4 weeks prior to first dose of study intervention.
- Adequate contraceptive precautions
You may not qualify if:
- 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
- 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.
- Was treated with 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jazz Pharmaceuticalslead
- Jazz Pharmaceuticals Ireland Limitedcollaborator
Study Sites (26)
Oncology Institute
Long Beach, California, 90805, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
The Oncology Institute
Lakeland, Florida, 33812, United States
Accellacare of McFarland
Ames, Iowa, 50010, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Maryland Oncology Hematology
Laurel, Maryland, 20707, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68124, United States
Astera Cancer Care (Formerly Regional Cancer Care Associates)
East Brunswick, New Jersey, 08816, United States
Medical Oncology Hematology Associates
Newark, New Jersey, 19713, United States
Hematology Oncology Associates of Central New York
Camillus, New York, 13031, United States
Sarah Cannon Research Institute (Nashville)
Nashville, Tennessee, 37203, United States
Texas Oncology DFW
Dallas, Texas, 75246, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Oncology Gulf Coast
Houston, Texas, 77024, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Shenandoah Oncology
Winchester, Virginia, 22601, United States
Northwest Medical Specialties
Puyallup, Washington, 98373, United States
Northwest Cancer Specialists
Vancouver, Washington, 98648, United States
University of Wisconsin
Madison, Wisconsin, 53706, United States
Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Hospital Clínico San Cecilio
Granada, Andalusia, 18007, Spain
Álvaro Cunqueiro Hospital
Vigo, Galicia, 36312, Spain
Hosp Beata María Ana de Jesús
Madrid, 28007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
September 24, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
August 1, 2030
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.