Actively Recruiting
A New Option for Post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6is
Led by Hunan Cancer Hospital · Updated on 2024-12-16
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of anlotinib-based combination therapy in female patients with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer (MBC) who have already been treated with CDK4/6 inhibitors. This study focuses on patients whose cancer has progressed after receiving standard treatments including CDK4/6 inhibitors combined with hormonal therapy, aiming to find new options for this resistant stage of disease. The study involves administering anlotinib, an oral multi-target tyrosine kinase inhibitor given daily for 14 days in each cycle, with doses adjusted based on tolerance. Anlotinib is combined with other agents such as eribulin, nab-paclitaxel, etoposide, capecitabine, pembrolizumab, sintilimab, or fulvestrant. This real-world study observes patients over an average of one year to assess treatment response and safety. Participants will be monitored through assessments of progression-free survival, objective response rate, disease control rate, overall survival up to five years, and treatment-emergent adverse events. The study includes regular evaluations of measurable lesions and overall health status. Women between 18 and 75 years old with confirmed HR+ HER2-negative breast cancer and prior CDK4/6 inhibitor treatment are eligible, with safety and effectiveness tracked throughout the study period.
CONDITIONS
Brief 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 with an ECOG score of 0-1 and an expected survival of at least 3 months
- Presence of measurable lesions according to RECIST 1.1 criteria
- Histopathologically confirmed hormone receptor-positive, HER2-negative breast cancer
- Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options
- 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, used as adjuvant or systemic treatment for advanced disease
You will not qualify if you...
- HER2-positive breast cancer confirmed by histology or cytology
- Discontinued therapy for reasons other than disease progression, such as adverse events or non-medical factors
- Presence of a second primary malignant tumor at enrollment
- Failure to complete CDK4/6 inhibitor therapy
- Pregnancy or breastfeeding
- Presence of uncontrolled third-space fluid accumulation such as pleural effusion, ascites, or pericardial effusion
- Previous treatment with anti-angiogenic agents including anlotinib, apatinib, or bevacizumab
- Currently receiving other anti-tumor treatments for any other cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants receiving anlotinib-based combination therapy are observed to assess treatment effects and safety.
Visits as per routine clinical care during treatment
Duration - Up to 5 years
Participants are followed to assess overall survival and long-term outcomes after treatment.
Follow-up visits according to clinical practice
Trial Site Locations
Total: 1 location
1
Hunan Provincial Tumor Hospital
Changsha, Hunan, China
Actively Recruiting
Research Team
Q
Quchang Ouyang
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here