Actively Recruiting
Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .
Led by Hunan Cancer Hospital · Updated on 2024-12-16
80
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4/6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4/6 inhibitor.
CONDITIONS
Official Title
Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- ECOG score of 0-1 and expected survival of at least 3 months
- Measurable lesions according to RECIST 1.1 criteria
- Histopathologically confirmed HR-positive and HER2-negative breast cancer
- Prior treatment with at least one line of CDK4/6 inhibitors and endocrine therapy
- Disease progression after aromatase inhibitor or fulvestrant combined with CDK4/6 inhibitors
- No remaining standard treatment options after multiple lines of advanced therapy
You will not qualify if you...
- HER2-positive breast cancer confirmed by histology or cytology
- Discontinuation of therapy due to reasons other than disease progression
- Presence of a second primary malignant tumor at enrollment
- Failure to complete CDK4/6 inhibitor therapy
- Pregnancy or breastfeeding
- Presence of third-space fluid accumulation that cannot be managed
- Prior treatment with anti-angiogenic agents including anlotinib, apatinib, or bevacizumab
- Receiving other anti-tumor treatments for other malignancies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Provincial Tumor Hospital
Changsha, Hunan, China
Actively Recruiting
Research Team
Q
Quchang Ouyang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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