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This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib dose escalation + trastuzumab deruxtecan | Experimental | Various doses of anlotinib (8 mg QD, 10 mg QD, and 12 mg QD) administered during dose escalation to determine the recommended phase 2 Dose (RP2D) + trastuzumab deruxtecan 5.4 mg/kg. Anlotinib at the RP2D + trastuzumab deruxtecan 5.4 mg/kg combination therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan | The RP2D is defined as the dose level for the dose expansion phase, based on safety, tolerability, efficacy collected during the dose escalation portion of the study. | up to 1 year |
| Objective Response Rate (ORR) | ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DCR) | DCR is defined as the percentage of cases with remission (PR+CR) and stable disease (SD) after treatment in the evaluable cases. | Up to approximately 3 years |
| Duration of Response (DOR) |
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Inclusion Criteria:
1. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jian Zhang | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| C000614160 | trastuzumab deruxtecan |
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| Trastuzumab deruxtecan | Drug | Trastuzumab deruxtecan is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. |
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DOR is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
| Up to approximately 3 years |
| Progression-free Survival (PFS) | PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first. | Up to approximately 3 years |
| Overall Survival (OS) | OS is defined as the time from the participant's first dose of study treatment to the date of death. | Up to approximately 3 years |
| Number of Participants With Adverse Events (AEs) | Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0). | Up to approximately 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |