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This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 | Drug | SHR-A1811: intravenous |
| |
| Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| CNS-ORR | CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first | up to 2 years |
| ORR | ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
Previous treatment with bevacizumab;
Participated in other drug clinical trials within 4 weeks before admission;
History of clinically significant lung diseaseï¼›
Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
Any other conditions that researchers believe that patients are unsuitable for this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiong huihua | Contact | 13886073988 | xionghuihua@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiong huihua | Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology | Principal Investigator |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Bevacizumab:intravenous |
|
| Up to 2 years |
| AE | Proportion of participants experienced adverse events during the study period | Up to 2 years |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |