A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
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
• 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