Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435429
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-24
Brief Title:
A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab Each in Combination With Physicians Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
A Phase 3 Randomized Open-label Multicenter Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physicians Choice Chemotherapy Compared to Trastuzumab in Combination With Physicians Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on or Are Intolerant to Previous Trastuzumab Deruxtecan Treatment
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The efficacy and safety of zanidatamab in combination with physicians choice of chemotherapy compared with trastuzumab in combination with physicians 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
Detailed Description:
Zanidatamab as a monotherapy or in combination with other antineoplastic agents has shown clinically meaningful efficacy against multiple HER2-positive advancedmetastatic tumors including in patients with metastatic breast cancer mBC Zanidatamab may offer a viable treatment option for patients with metastatic HER2-positive breast cancer
The primary objective of the study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy The secondary objectives of the study will include further comparing the efficacy safety and tolerability patient-reported tolerability and patient-reported physical functioning of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy The pharmacokinetics and immunogenicity of zanidatamab in combination with chemotherapy will also be evaluated
The primary objective of the study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy The secondary objectives of the study will include further comparing the efficacy safety and tolerability patient-reported tolerability and patient-reported physical functioning of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy The pharmacokinetics and immunogenicity of zanidatamab in combination with chemotherapy will also be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508960-31-00 | OTHER | EU CTR | None |