A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With … (NCT07102381) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
United States125 participantsStarted 2025-09-24
Plain-language summary
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 participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
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 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.