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Trial Title:
SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases
NCT ID:
NCT06361979
Condition:
Breasr Cancer
Conditions: Official terms:
Brain Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
SHR-A1811: intravenous
Arm group label:
ARM1
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab:intravenous
Arm group label:
ARM1
Summary:
This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast
Cancer with brain metastases
Criteria for eligibility:
Criteria:
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.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Huihua Xiong
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06361979
