Actively Recruiting
Study on the Treatment of HER2-negative Breast Cancer Brain Metastases With Radiotherapy Combined With Anlotinib
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-02-09
39
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Angiogenesis inhibition represents a significant therapeutic target in breast cancer; however, despite its theoretical feasibility, progress in advanced breast cancer has been slow. Currently, there is a lack of prospective data supporting the selection of tyrosine kinase inhibitors (TKIs) in combination with local therapy. This phase II study aims to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) or whole-brain radiotherapy (WBRT) combined with anlotinib in patients with HER2-negative advanced breast cancer and brain metastases.
CONDITIONS
Official Title
Study on the Treatment of HER2-negative Breast Cancer Brain Metastases With Radiotherapy Combined With Anlotinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years at consent signing
- Karnofsky Performance Status score of 70 or higher, or 60 if due to neurological symptoms
- HER2-negative status confirmed by pathology, with specific test results
- Brain metastases confirmed by contrast-enhanced cranial MRI with at least one measurable lesion
- At least 2 weeks washout after prior anti-tumor therapy excluding intracranial metastases treatments
- Prior treatment toxicities resolved to Grade 2 or below, except alopecia and blood toxicities
- Stable corticosteroid dose for at least one week before enrollment
- Life expectancy of at least 3 months
- Adequate blood counts and organ function meeting specified laboratory criteria
- Women of childbearing potential must be surgically sterile, postmenopausal, or agree to use effective contraception
- Negative serum pregnancy test within 7 days before enrollment if applicable
- Not breastfeeding
- Voluntary participation with informed consent
You will not qualify if you...
- Extensive leptomeningeal or hemorrhagic brain metastases
- Uncontrolled seizures
- Severe or uncontrolled medical conditions preventing study participation
- Problems affecting oral drug intake like inability to swallow or intestinal obstruction
- Known allergy to anlotinib or study drug components
- History of immunodeficiency including HIV or organ transplant
- Significant cardiovascular disease or recent heart attack
- Active or uncontrolled infection needing systemic treatment within 2 weeks except simple infections
- History of other cancers except cured basal cell carcinoma of skin or cervical carcinoma in situ
- Pregnant, breastfeeding, or planning pregnancy during or 6 months after treatment
- Unwillingness to use contraception during and 6 months after treatment
- Inability to undergo contrast-enhanced MRI
- Previous anti-angiogenic TKI therapy with intracranial progression
- Unable to comply with study follow-up requirements
- Any other condition making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
C
Chi Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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