A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participant
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
| Condition(s) | HER2-positive Breast Cancer, Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 | Inclusion Criteria: 1. Has Stage II or III histologically confirmed invasive breast carcinoma. 2. Has histologically confirmed HER2-positive breast cancer 3. Has a known hormone receptor (HR) status of the primary tumor 4. 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. 5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate organ function 8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 4 weeks prior to first dose of study inter |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Jazz Pharmaceuticals |
| Locations | Long Beach, California, United States; Denver, Colorado, United States; Lakeland, Florida, United States; Ames, Iowa, United States; Shreveport, Louisiana, United States; Scarborough, Maine, United States (+20 more sites) |
| Start date | 2025-09-24 |
| NCT ID | NCT07102381 |
| Official listing | https://clinicaltrials.gov/study/NCT07102381 |