🏛️ Verified NIH Record • Updated 2026-08-24
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer (NCT07102381)
🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Jazz Pharmaceuticals
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (14 items).
Location: Oncology Institute — Long Beach, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (35 Sites)
- Oncology Institute — Long Beach, California
- Cancer & Blood Research Center — Los Alamitos, California
- Rocky Mountain Cancer Centers — Denver, Colorado
- Holy Cross Hospital — Fort Lauderdale, Florida
- The Oncology Institute — Lakeland, Florida
- Accellacare of McFarland — Ames, Iowa
- LSU Health Sciences Center — Shreveport, Louisiana
- New England Cancer Specialists — Scarborough, Maine
- Maryland Oncology Hematology — Laurel, Maryland
- Henry Ford Hospital — Detroit, Michigan
- Cancer Partners of Nebraska — Lincoln, Nebraska
- Nebraska Cancer Specialists — Omaha, Nebraska
- Astera Cancer Care (Formerly Regional Cancer Care Associates) — East Brunswick, New Jersey
- Medical Oncology Hematology Associates — Newark, New Jersey
- The University of New Mexico — Albuquerque, New Mexico
- Hematology Oncology Associates of Central New York — Camillus, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Levine Cancer — Charlotte, North Carolina
- Sarah Cannon Research Institute (Nashville) — Nashville, Tennessee
- Texas Oncology DFW — Dallas, Texas
- The University of Texas Southwestern Medical Center — Dallas, Texas
- Texas Oncology Gulf Coast — Houston, Texas
- UT Health San Antonio, Mays Cancer Center — San Antonio, Texas
- Virginia Cancer Specialists — Fairfax, Virginia
- Virginia Oncology Associates — Norfolk, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.