Actively Recruiting
The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
Led by Zhejiang Cancer Hospital · Updated on 2021-10-12
40
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality. Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET. Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer. This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.
CONDITIONS
Official Title
The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Histologically confirmed HR-positive, HER2-negative locally advanced or metastatic breast cancer
- Premenopausal women must have effective ovarian function suppression (drug or surgery)
- At least one measurable breast cancer lesion per RECIST 1.1 criteria
- No more than one prior systemic chemotherapy for metastatic disease
- Disease relapse within 12 months after at least 24 months of endocrine adjuvant therapy, or progression after at least 6 months of endocrine salvage therapy
- Normal function of main organs and bone marrow with specified blood counts and liver and kidney tests
- Signed informed consent
You will not qualify if you...
- Prior treatment with fulvestrant or anti-angiogenic drugs, or allergy to study components
- Presence of visceral crisis
- Uncontrolled or extensive central nervous system metastases
- Inability to swallow
- Abnormal blood clotting function
- Tumor invasion of major blood vessels with risk of fatal bleeding
- Pleural or pericardial effusion requiring repeated drainage
- Hypertension not controlled by one antihypertensive medication
- Unstable angina, recent myocardial infarction within 6 months, serious arrhythmias
- History of immunodeficiency or organ transplantation
- Poorly controlled diabetes
- Significant proteinuria (urine protein ≥1.0g/24h)
- Bleeding disorders or history of bleeding
- Unhealed wounds, ulcers, or fractures
- Arterial or venous thrombosis within 6 months
- Participation in other anti-tumor drug trials
- Other diseases or disabilities posing safety risks per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiaojia Wang
CONTACT
J
Jian Huang
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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