Study of SHR-A1811 in HER2-expression Advanced Breast Cancer with Brain Metastases
NCT ID: NCT05769010
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
125 participants
INTERVENTIONAL
2023-03-31
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
HER2-positive: SHR-A1811
SHR-A1811
SHR-A1811: intravenous
Arm 2
HER2-positive: SHR-A1811 and pyrotinib
SHR-A1811
SHR-A1811: intravenous
Pyrotinib
Pyrotinib: oral
Arm 3
HER2-positive: SHR-A1811 and bevacizumab
SHR-A1811
SHR-A1811: intravenous
Bevacizumab
Bevacizumab: intravenous
Arm 4
HER2-low: SHR-A1811
SHR-A1811
SHR-A1811: intravenous
Arm 5
HER2-low: SHR-A1811 and bevacizumab
SHR-A1811
SHR-A1811: intravenous
Bevacizumab
Bevacizumab: intravenous
Interventions
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SHR-A1811
SHR-A1811: intravenous
Pyrotinib
Pyrotinib: oral
Bevacizumab
Bevacizumab: intravenous
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Min Yan, MD
Chief Physician
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HNCH-MBC12-BM04
Identifier Type: OTHER
Identifier Source: secondary_id
HNCH-MBC12
Identifier Type: -
Identifier Source: org_study_id
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