A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
NCT ID: NCT07102381
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
125 participants
INTERVENTIONAL
2025-09-24
2030-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zanidatamab with paclitaxel
Zanidatamab in combination with chemotherapy paclitaxel
Zanidatamab
Administered intravenously (IV)
Paclitaxel
Administered intravenously (IV)
Zanidatamab with docetaxel and carboplatin
Zanidatamab in combination with chemotherapy docetaxel and carboplatin
Zanidatamab
Administered intravenously (IV)
Docetaxel
Administered intravenously (IV)
Carboplatin
Administered intravenously (IV)
Trastuzumab 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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zanidatamab
Administered intravenously (IV)
Paclitaxel
Administered intravenously (IV)
Docetaxel
Administered intravenously (IV)
Carboplatin
Administered intravenously (IV)
Trastuzumab
Administered intravenously (IV)
Pertuzumab
Administered intravenously (IV)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Has histologically confirmed HER2-positive breast cancer
3. Has a known hormone receptor (HR) status of the primary tumor
4. 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.
5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate organ function
8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 4 weeks prior to first dose of study intervention.
9. Adequate contraceptive precautions
Exclusion Criteria
2. Has bilateral breast cancer.
3. 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.
4. Has uncontrolled hypertension
5. Has significant symptoms from peripheral neuropathy
6. Has an active uncontrolled infection
7. 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.
8. Known active hepatitis B or C infection.
9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ.
10. Was treated with chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
12. Receipt of a live vaccine within 4 weeks prior to enrollment
13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jazz Pharmaceuticals Ireland Limited
INDUSTRY
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rocky Mountain Cancer Centers
Denver, Colorado, United States
The Oncology Institute
Lakeland, Florida, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
New England Cancer Specialists
Scarborough, Maine, United States
Maryland Oncology Hematology
Laurel, Maryland, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Astera Cancer Care (Formerly Regional Cancer Care Associates)
East Brunswick, New Jersey, United States
Medical Oncology Hematology Associates
Newark, New Jersey, United States
Hematology Oncology Associates of Central New York
Camillus, New York, United States
Sarah Cannon Research Institute (Nashville)
Nashville, Tennessee, United States
Texas Oncology DFW
Dallas, Texas, United States
Texas Oncology Gulf Coast
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Shenandoah Oncology
Winchester, Virginia, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-523204-68-00
Identifier Type: CTIS
Identifier Source: secondary_id
JZP598-208
Identifier Type: -
Identifier Source: org_study_id