Breasr Cancer
Conditions
Brief summary
This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases
Interventions
DRUGSHR-A1811
SHR-A1811: intravenous
DRUGBevacizumab
Bevacizumab:intravenous
Sponsors
Huihua Xiong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old; 2. Pathologically confirmed HER2-positive breast cancer; 3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment; 4. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. 5. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed; 6. Adequate function of major organs-
Exclusion criteria
1. 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; 2. Previous treatment with bevacizumab; 3. Participated in other drug clinical trials within 4 weeks before admission; 4. History of clinically significant lung disease； 5. 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. 6. 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.). 7. Any other conditions that researchers believe that patients are unsuitable for this study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CNS-ORR | Up to 2 years | CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to 2 years | PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first |
| ORR | Up to 2 years | 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 |
| AE | Up to 2 years | Proportion of participants experienced adverse events during the study period |
Contacts
Primary ContactXiong huihua
Outcome results
None listed