Actively Recruiting
A Phase 2 Randomized Study Evaluating Zanidatamab with Chemotherapy for HER2-positive Breast Cancer
Led by Jazz Pharmaceuticals · Updated on 2026-04-29
125
Participants Needed
26
Research Sites
134 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
Researchers are evaluating the safety and effectiveness of zanidatamab combined with chemotherapy in treating people with early-stage HER2-positive breast cancer. This Phase 2 study compares zanidatamab plus different chemotherapy regimens to trastuzumab and pertuzumab with chemotherapy. The goal is to see how well these treatments work before surgery in participants with this specific type of breast cancer. Participants receive one of three treatment combinations: zanidatamab with paclitaxel, zanidatamab with docetaxel and carboplatin, or trastuzumab and pertuzumab with docetaxel and carboplatin. All drugs are given through intravenous infusions. The treatments are administered before surgery in a neoadjuvant setting, and participants will have either a mastectomy or breast conserving surgery after completing therapy. During the study, participants will be monitored for tumor response, side effects, and overall health. Researchers will assess measures like pathologic complete response, residual cancer burden, adverse events, and survival outcomes up to nearly four years. Various blood tests and questionnaires will track drug levels, immune responses, and patient-reported symptoms. The study lasts up to about 46 months, including treatment and follow-up periods to evaluate long-term effects and safety.
CONDITIONS
Brief 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 status of the primary tumor
- Has multifocal or multicentric disease with the largest tumor at least 2 cm and HER2-positive
- Agrees to undergo mastectomy or breast conserving surgery after neoadjuvant therapy
- Has an ECOG performance status of 0 or 1
- Has adequate organ function
- Has a left ventricular ejection fraction of 50% or higher by recent ECHO or MUGA
- Uses adequate contraceptive precautions
You will not qualify if you...
- Has Stage IV (metastatic) breast cancer
- Has bilateral breast cancer
- Has severe or uncontrolled medical conditions affecting study participation
- Has uncontrolled high blood pressure
- Has significant symptoms from peripheral neuropathy
- Has an active uncontrolled infection
- Has life-threatening allergies to monoclonal antibodies or study drugs
- Has active hepatitis B or C infection
- Has another cancer diagnosed within the last 5 years except certain skin or in-situ cancers
- Has received prior chemotherapy, anti-HER2 therapy, radiation, endocrine, or experimental therapy for invasive breast cancer
- Plans to receive other investigational or anti-cancer treatments not in the study
- Received a live vaccine within 4 weeks before enrollment
- Has known allergies to components of study drugs including chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 months
Participants receive Zanidatamab in combination with chemotherapy drugs intravenously as part of neoadjuvant therapy for HER2-positive breast cancer.
Multiple intravenous treatment visits over several months
Duration - Up to 46 months
Participants are monitored for treatment-emergent adverse events, survival outcomes, and antibody responses after completing treatment.
Periodic visits for safety and outcome assessments
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
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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