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The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab Rezetecan for Injection | Experimental | Trastuzumab Rezetecan for Injection, different doses. |
|
| Trastuzumab Deruxtecan for Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab Rezetecan for Injection | Drug | Trastuzumab Rezetecan for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS). | Every 6 weeks after administration, approximately 14 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR). | Every 6 weeks after administration, approximately 14 months. | |
| Duration of response (DoR). | Every 6 weeks after administration, approximately 14 months. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Zhang | Contact | +86-0518-82342973 | xia.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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Different dose groups of Trastuzumab Rezetecan compared with Trastuzumab Deruxtecan.
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| Trastuzumab Deruxtecan for Injection | Drug | Trastuzumab Deruxtecan for injection. |
|
| Clinical benefit rate (CBR). |
| Every 6 weeks after administration, approximately 14 months. |
| Adverse events (AEs). | Graded according to NCI-CTCAE version 5.0. | From the first dose administration until 40 days after the last dose administration. |
| Laboratory test indicators, including complete blood count. | From the first dose administration until 40 days after the last dose administration. |
| Laboratory test indicators, including urinalysis. | From the first dose administration until 40 days after the last dose administration. |
| Laboratory test indicators, including virology screening. | From the first dose administration until 40 days after the last dose administration. |
| Serum concentrations of Trastuzumab Rezetecan. | Until the end of treatment, approximately 14 months. |
| ID | Term |
|---|---|
| D007267 | Injections |
| C000614160 | trastuzumab deruxtecan |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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