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Clinical Trial NCT07102381 (EmpowHER 208) for HER2-positive Breast Cancer, Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Jazz PharmaceuticalsA Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer (EmpowHER 208) Phase 2 125
Clinical Trial NCT07102381 (EmpowHER 208) is designed to study Treatment for HER2-positive Breast Cancer, Breast Cancer. It is a Phase 2 interventional study that is recruiting, having started on September 24, 2025, with plans to enroll 125 participants. Led by Jazz Pharmaceuticals, it is expected to complete by August 1, 2030. The latest data from ClinicalTrials.gov was last updated on March 12, 2026.
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
Official Title
A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Conditions
HER2-positive Breast CancerBreast CancerOther Study IDs
- EmpowHER 208
- JZP598-208
- 2025-523204-68-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2025-09-24
Last Update Posted
2026-03-12
Completion Date (Estimated)
2030-08-01
Enrollment (Estimated)
125
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
HER2-positive early breast cancer
invasive breast carcinoma
zanidatamab
breast neoplasm
invasive breast carcinoma
zanidatamab
breast neoplasm
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorZanidatamab with paclitaxel Zanidatamab in combination with chemotherapy paclitaxel | Zanidatamab Administered intravenously (IV) Paclitaxel Administered intravenously (IV) |
Active ComparatorZanidatamab with docetaxel and carboplatin Zanidatamab in combination with chemotherapy docetaxel and carboplatin | Zanidatamab Administered intravenously (IV) Docetaxel Administered intravenously (IV) Carboplatin Administered intravenously (IV) |
Active ComparatorTrastuzumab and pertuzumab with docetaxel and carboplatin Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin | Docetaxel Administered intravenously (IV) Carboplatin Administered intravenously (IV) Trastuzumab Administered intravenously (IV) Pertuzumab Administered intravenously (IV) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | EFS is defined as the time (in months) from randomization to disease progression, disease recurrence, or death from any cause | 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. | 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. | 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. | 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. | Up to 23 months |
Serum Concentrations of Zanidatamab | Up to 18 months | |
Number of Participants Positive for Anti-drug Antibodies to Zanidatamab | Up to 18 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Jazz PharmaceuticalsJazz Pharmaceuticals Ireland LimitedStudy Central Contact
Contact: Clinical Trial Disclosure & Transparency, 215-832-3750, [email protected]
21 Study Locations in 1 Countries
California
Oncology Institute, Long Beach, California, 90805, United States
Recruiting
Colorado
Rocky Mountain Cancer Centers, Denver, Colorado, 80218, United States
Recruiting
Florida
The Oncology Institute, Lakeland, Florida, 33812, United States
Recruiting
Iowa
Accellacare of McFarland, Ames, Iowa, 50010, United States
Recruiting
Louisiana
LSU Health Sciences Center, Shreveport, Louisiana, 71103, United States
Recruiting
Maine
New England Cancer Specialists, Scarborough, Maine, 04074, United States
Recruiting
Maryland
Maryland Oncology Hematology, Laurel, Maryland, 20707, United States
Recruiting
Nebraska
Cancer Partners of Nebraska, Lincoln, Nebraska, 68516, United States
Recruiting
Nebraska Cancer Specialists, Omaha, Nebraska, 68124, United States
Recruiting
New Jersey
Astera Cancer Care (Formerly Regional Cancer Care Associates), East Brunswick, New Jersey, 08816, United States
Recruiting
Medical Oncology Hematology Associates, Newark, New Jersey, 19713, United States
Recruiting
New York
Hematology Oncology Associates of Central New York, Camillus, New York, 13031, United States
Recruiting
Tennessee
Sarah Cannon Research Institute (Nashville), Nashville, Tennessee, 37203, United States
Recruiting
Texas
Texas Oncology DFW, Dallas, Texas, 75246, United States
Recruiting
The University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States
Recruiting
Texas Oncology Gulf Coast, Houston, Texas, 77024, United States
Recruiting
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
Recruiting
Virginia Oncology Associates, Norfolk, Virginia, 23502, United States
Recruiting
Shenandoah Oncology, Winchester, Virginia, 22601, United States
Recruiting
Washington
Northwest Medical Specialties, Puyallup, Washington, 98373, United States
Recruiting
Northwest Cancer Specialists, Vancouver, Washington, 98648, United States
Recruiting