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Trial Title:
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer with Brain Metastases
NCT ID:
NCT05769010
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Brain Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
SHR-A1811: intravenous
Arm group label:
Arm 1
Arm group label:
Arm 2
Arm group label:
Arm 3
Arm group label:
Arm 4
Arm group label:
Arm 5
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
Pyrotinib: oral
Arm group label:
Arm 2
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab: intravenous
Arm group label:
Arm 3
Arm group label:
Arm 5
Summary:
This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast
Cancer patients with brain metastases.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Females ≥18 yrs old;
2. Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
3. At least one measurable intracranial lesion according to RANO-BM criteria, which had
not received local treatment;
4. Without prior cranial radiation and had no indication for immediate local treatment
or refuse to local treatment;
5. More than 2 weeks from last systemic treatment; patients with new brain lesions
after craniocerebral surgery were admitted if no radiotherapy was performed.
Patients with HER2-Low disease must not have systemic treatment for brain
metastases.
6. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
7. Life expectancy is not less than 6 months.
8. Adequate function of major organs.
Exclusion Criteria:
1. Leptomeningeal involvement;
2. CNS complications requiring emergency neurosurgical intervention (e.g. excision,
shunt tube placement);or uncontrolled symptomatic brain metastases;
3. 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;
4. Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were
excluded from Arm 2, and those who had progressed on previous bevacizumab therapy
were excluded from Arm 3;
5. No concurrent antitumor therapy for metastatic cancer other than the study
treatment;
6. Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy
within 2 weeks or endocrine therapy within 1 week prior to enrolment;
7. Participated in other drug clinical trials within 4 weeks before admission;
8. History of clinically significant lung disease；
9. 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.
10. 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.).
11. Any other conditions that researchers believe that patients are unsuitable for this
study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Min Yan, Professor
Phone:
+86 15713857388
Email:
ym200678@126.com
Start date:
March 31, 2023
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05769010
