Actively Recruiting
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Led by Jazz Pharmaceuticals · Updated on 2026-04-29
125
Participants Needed
26
Research Sites
253 weeks
Total Duration
On this page
Sponsors
J
Jazz Pharmaceuticals
Lead Sponsor
J
Jazz Pharmaceuticals Ireland Limited
Collaborating Sponsor
AI-Summary
What this Trial 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
CONDITIONS
Official Title
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 could affect 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, except 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.
AI-Screening
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Trial Site Locations
Total: 26 locations
1
Oncology Institute
Long Beach, California, United States, 90805
Actively Recruiting
2
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
3
The Oncology Institute
Lakeland, Florida, United States, 33812
Actively Recruiting
4
Accellacare of McFarland
Ames, Iowa, United States, 50010
Actively Recruiting
5
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
Actively Recruiting
6
New England Cancer Specialists
Scarborough, Maine, United States, 04074
Actively Recruiting
7
Maryland Oncology Hematology
Laurel, Maryland, United States, 20707
Actively Recruiting
8
Cancer Partners of Nebraska
Lincoln, Nebraska, United States, 68516
Actively Recruiting
9
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68124
Actively Recruiting
10
Astera Cancer Care (Formerly Regional Cancer Care Associates)
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
11
Medical Oncology Hematology Associates
Newark, New Jersey, United States, 19713
Actively Recruiting
12
Hematology Oncology Associates of Central New York
Camillus, New York, United States, 13031
Actively Recruiting
13
Sarah Cannon Research Institute (Nashville)
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
Texas Oncology DFW
Dallas, Texas, United States, 75246
Actively Recruiting
15
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
16
Texas Oncology Gulf Coast
Houston, Texas, United States, 77024
Actively Recruiting
17
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
19
Shenandoah Oncology
Winchester, Virginia, United States, 22601
Actively Recruiting
20
Northwest Medical Specialties
Puyallup, Washington, United States, 98373
Actively Recruiting
21
Northwest Cancer Specialists
Vancouver, Washington, United States, 98648
Actively Recruiting
22
University of Wisconsin
Madison, Wisconsin, United States, 53706
Actively Recruiting
23
Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
24
Hospital Clínico San Cecilio
Granada, Andalusia, Spain, 18007
Actively Recruiting
25
Álvaro Cunqueiro Hospital
Vigo, Galicia, Spain, 36312
Actively Recruiting
26
Hosp Beata María Ana de Jesús
Madrid, Spain, 28007
Actively Recruiting
Research Team
C
Clinical Trial Disclosure & Transparency
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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