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A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

StatusRecruiting
PhasePhase 3
Started2024-08-13
View on ClinicalTrials.gov ↗

Amendment history

2026-02-06
Study Status, Eligibility v41
Primary completion date2028-09-26→2028-04-28
Completion date2031-11-26→2030-10-18
Eligibility criteria+456 characters
[...] t cancer according to ASCO-CAP Guidelines as evaluated by a sponsor-designated central laboratory Participants with unresectable or metasta [...] gressed on, or are intolerant to, previous T-DXd treatment. Must have received at least 2 lines of HER2-directed therapy for their metastatic disease. Prior HER2-targeted neo-adjuvant or adjuvant therapy that resulted in relapse within 6 months of the completion of therapy will be considered a line of treatment for metastatic disease. Based on the physician' [...] Has measurable disease per RECIST version 1.1. Is eligible t [...] on as specified in the protocol. Has crea [...]
2025-12-01
Study Status, Contacts/Locations v40
Study sites165→166
2025-10-24
Study Status, Contacts/Locations v39
Study sites164→165
2025-10-24
Study Status, Contacts/Locations v38
Study sites163→164
2025-10-06
Study Status, Contacts/Locations v37
Study sites161→163
Show 36 earlier versions
2025-09-23
Study Status, Contacts/Locations v36
Study sites160→161
2025-09-15
Study Status, Contacts/Locations v35
Study sites159→160
2025-09-08
Study Status v34
Re-verified, no change to tracked fields
2025-08-22
Study Status, Contacts/Locations v33
Study sites157→159
2025-08-01
Study Status, Contacts/Locations v32
Study sites154→157
2025-07-25
Study Status, Contacts/Locations v31
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2025-07-18
Study Status, Contacts/Locations v30
Study sitesdetails revised at 4 of 151 sites
2025-07-14
Study Status, Contacts/Locations v29
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2025-07-03
Study Status, Contacts/Locations v28
Study sites144→150
2025-07-01
Study Status, Contacts/Locations v27
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2025-06-20
Study Status, Contacts/Locations v26
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2025-06-16
Study Status, Contacts/Locations v25
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2025-06-06
Study Status, Contacts/Locations v24
Study sites130→136
2025-05-30
Study Status, Contacts/Locations v23
Study sites125→130
2025-05-29
Study Status, Contacts/Locations v22
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2025-05-19
Study Status, Contacts/Locations v21
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2025-05-09
Study Status, Contacts/Locations v20
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2025-05-02
Study Status, Contacts/Locations v19
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2025-04-29
Study Status, Contacts/Locations v18
Study sites106→111
2025-04-07
Study Status, Contacts/Locations v17
Study sites102→106
2025-03-31
Study Status, Contacts/Locations v16
Study sites100→102
2025-03-24
Study Status, Contacts/Locations v15
Study sites97→100
2025-03-17
Study Status, Contacts/Locations v14
Study sites92→97
2025-03-05
Study Status, Contacts/Locations v13
Study sites85→92
2025-02-24
Study Status, Contacts/Locations v12
Study sites82→85
2025-02-18
Study Status, Contacts/Locations v11
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2025-02-11
Study Status, Contacts/Locations v10
Study sites70→78
2025-02-03
Study Status, Contacts/Locations v9
Study sites68→70
2025-01-21
Study Status, Contacts/Locations v8
Study sites63→68
2025-01-13
Study Status, Contacts/Locations v7
Study sites60→63
2025-01-06
Study Status, Contacts/Locations v6
Study sites57→60
2024-12-23
Study Status, Contacts/Locations v5
Study sites41→57
2024-12-17
Study Status, Contacts/Locations v4
Study sites37→41
2024-12-13
Study Status, Contacts/Locations v3
Study sites10→37
2024-08-26
Study Status, Contacts/Locations v2
Start dateestimated 2024-07-30→confirmed 2024-08-13
Study sites1→10
2024-07-30
Not Yet Recruiting→Recruiting Study Identification, Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2031-04-25→2028-09-26
Completion date2031-04-25→2031-11-26
Start date2024-07-16→2024-07-30
Study sites0→1
Secondary endpoints14 entries, revised
Proportion of All Treated Participants, As Treated, Reporting Symptomatic Adverse Events While On Treatment Based on PROPatient-CTCAEreported Outcome-Common Terminology Criteria for AEs and EORTCEuropean Organisation for Research and Treatment of Cancer Item Library Proportion of All Treated Participants, As Treated, Reporting Overall Side-effect Bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5) Proportion of Treated Participants, As Treated, With Mainta [...] ent Based On The Physical Functioning Subscale of the EORTC Quality of Life Questionnaire Cor [...] [...]
Study title-44 characters
A Phase 3, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of Zanidatamab to T [...]
2024-05-24
Original filing
The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
Trial Details
NCT Number NCT06435429
Lead Sponsor Jazz Pharmaceuticals
Conditions Metastatic HER2-positive Breast Cancer
Enrollment 550 participants
Start Date 2024-08-13
Primary Completion 2028-04-28 (estimated)
Study Completion 2030-10-18 (estimated)
Updated on ClinicalTrials.gov 2026-02-10