NCT07102381 · Jazz Pharmaceuticals
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
(EmpowHER 208)
What this study is about
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
View original scientific description
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
Interventions
DRUG
Zanidatamab
Administered intravenously (IV)
DRUG
Paclitaxel
Administered intravenously (IV)
DRUG
Docetaxel
Administered intravenously (IV)
DRUG
Carboplatin
Administered intravenously (IV)
DRUG
Trastuzumab
Administered intravenously (IV)
DRUG
Pertuzumab
Administered intravenously (IV)
Primary outcome measures
Number of participants with pCR
Time frame: Up to 8 months
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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
Exclusion criteria
- 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. 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
Where
- Long Beach, California
- Los Alamitos, California
- Denver, Colorado
- Fort Lauderdale, Florida
- Lakeland, Florida
- Ames, Iowa
- Shreveport, Louisiana
- Scarborough, Maine
- Laurel, Maryland
- Detroit, Michigan
- Lincoln, Nebraska
- Omaha, Nebraska
And 16 more locations — see the full list below.
Collaborators
Jazz Pharmaceuticals Ireland Limited
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations