A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Recruiting now · Phase 2

Conditions studied: HER2-positive Breast Cancer, Breast Cancer

In brief

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

Key facts

Study ID

NCT07102381

Run by

Jazz Pharmaceuticals

People needed

125

Starts

2025-09-24

Expected to finish

2030-08-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Oncology Institute — Long Beach, California, United States (enrolling)
• Cancer & Blood Research Center — Los Alamitos, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
• Holy Cross Hospital — Fort Lauderdale, Florida, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Levine Cancer — Charlotte, North Carolina, United States (enrolling)
• Sarah Cannon Research Institute (Nashville) — Nashville, Tennessee, United States (enrolling)
• Texas Oncology DFW — Dallas, Texas, United States (enrolling)
• Texas Oncology Gulf Coast — Houston, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)
• Shenandoah Oncology — Winchester, Virginia, United States (enrolling)
• Northwest Medical Specialties — Puyallup, Washington, United States (enrolling)
• Northwest Cancer Specialists — Vancouver, Washington, United States (enrolling)
• University of Wisconsin — Madison, Wisconsin, United States (enrolling)
• Accellacare of McFarland — Ames, Iowa, United States (enrolling)
• New England Cancer Specialists — Scarborough, Maine, United States (enrolling)
• Maryland Oncology Hematology — Laurel, Maryland, United States (enrolling)
• Cancer Partners of Nebraska — Lincoln, Nebraska, United States (enrolling)
• Medical Oncology Hematology Associates — Newark, New Jersey, United States (enrolling)
• The University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• Hematology Oncology Associates of Central New York — Camillus, New York, United States (enrolling)
• The Oncology Institute — Lakeland, Florida, United States
• Hospital Clínico San Cecilio — Granada, Andalusia, Spain
• LSU Health Sciences Center — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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