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

Study acronym: EmpowHER 208
StatusRecruiting
PhasePhase 2
Started2025-09-24
View on ClinicalTrials.gov ↗

Amendment history

2026-10-02
Trial sites expanded: 35 → 44 locations
2026-08-24
Study Status, Contacts/Locations v12
Study sites33→35
2026-07-14
Study Status, Contacts/Locations v11
Trial sites expanded: 30 → 33 locations
2026-06-30
Study Status, Outcome Measures, Eligibility, Contacts/Locations v10
Trial sites expanded: 26 → 30 locations
Eligibility criteria+301 characters
Inclusion Criteria: Has newly diagnosed Stage II or III histologically confirmed invasive breast ca [...] ≥ 50% as determined by either ECHO or MUGA obtained within 46 weeks prior to first dose of study interventionrandomization. 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 Exclusion Criteria: Has Stage IV (metastatic) breast cancer. [...] tous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral du [...] [...]
Secondary endpointsdetails revised at 1 of 11 entries
2026-04-28
Study Status, Contacts/Locations v9
Trial sites expanded: 21 → 26 locations
Show 8 earlier versions
2026-03-11
Study Status, Contacts/Locations v8
Study sites20→21
2026-02-13
Study Status, Contacts/Locations v7
Study sites18→20
2026-01-16
Study Status, Contacts/Locations v6
Study sites17→18
2025-12-16
Study Status, Contacts/Locations v5
Study sites13→17
2025-11-24
Study Status, Contacts/Locations v4
Study sites10→13
2025-10-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09-01→confirmed 2025-09-24
Study sites2→10
2025-09-08
Study Status, Contacts/Locations v2
Study sites0→2
2025-08-07
Study Status v1
Re-verified, no change to tracked fields
2025-07-28
Original filing
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
Trial Details
NCT Number NCT07102381
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Jazz Pharmaceuticals Ireland Limited
Conditions HER2-positive Breast Cancer, Breast Cancer
Enrollment 125 participants
Start Date 2025-09-24
Primary Completion 2028-01-01 (estimated)
Study Completion 2030-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-10-01