Actively Recruiting
Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis
Led by Fudan University · Updated on 2025-02-06
74
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In phase Ib, our study is aimed to evaluate the safety and tolerance of SHR-A1811 combined with pyrotinib in breast cancer with brain metastasis, and confirm the recommended phase 2 dose combined with preliminary results of efficacy. In phase II, our study is aimed to evaluate the efficacy and safety of SHR-A1811 combined with pyrotinib and bevacizumab at RP2D in breast cancer with brain metastasis.
CONDITIONS
Official Title
Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status score between 0 and 2
- Life expectancy of at least 3 months
- Brain metastasis confirmed by MRI with at least one measurable brain lesion and no prior radiotherapy
- Stable dosage of mannitol or hormone therapy for brain metastasis for at least one week before enrollment
- Adequate organ and marrow function
- Recovery from prior anti-tumor treatment side effects to grade 1 or less, except alopecia and hyperpigmentation
- Willing and able to provide written informed consent and comply with study visits and procedures
You will not qualify if you...
- Leptomeningeal metastasis or cystic metastatic brain lesions
- Uncontrolled third space fluid such as massive ascites, pleural or pericardial effusion
- CNS complications needing emergency intervention or poorly controlled brain metastasis symptoms
- Prior use of bevacizumab or EGFR-TKI with disease progression or less than 3 months from stopping to progression
- Recent whole brain radiotherapy, chemotherapy, surgery, trastuzumab or endocrine therapy within specified time frames before study treatment
- Moderate to severe lung disease affecting breathing, including grade 3 or higher interstitial lung disease
- Use of full-dose anticoagulants or certain anti-inflammatory drugs within 10 days before enrollment
- Unhealed wounds, active gastric ulcers, or other conditions increasing bleeding risk
- Known bleeding disorders or hereditary hemorrhagic tendencies
- Participation in other drug trials within 2 weeks before enrollment
- Use of other antitumor systemic treatments during the study except for bisphosphonates
- Other malignancies within 5 years unless disease-free for 3 years except certain treated cancers
- Significant heart problems including heart failure, angina needing treatment, serious valve or rhythm issues, or abnormal QTc on ECG
- Uncontrolled high blood pressure
- Immunodeficiency conditions including HIV, organ transplant history, or active infections
- Hypersensitivity to study drugs or their ingredients
- Pregnant or breastfeeding women or those unwilling to use contraception
- Inability to swallow or factors affecting drug absorption
- Any other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan Cancer Hospital
Shanghai, Shanghai Municipality, China, 200230
Actively Recruiting
Research Team
H
Hongxia Wang, Chief physician
CONTACT
T
Ting Li, Associate chief physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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