Anlotinib-containing regimens in HR+ advanced breast cancer after prior CDK4/6 inhibitor progression.
Yifei Chen, Binliang Liu, Zhanhong Chen...
https://pubmed.ncbi.nlm.nih.gov/42342669/Actively Recruiting
Led by Hunan Cancer Hospital · Updated on 2024-12-16
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
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 CDK46 inhibitors. This study focuses on patients whose cancer has progressed after receiving standard treatments including CDK46 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 CDK46 inhibitor treatment are eligible, with safety and effectiveness tracked throughout the study period.
CONDITIONS
Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive(HR+) Metastatic Breast Cancer(MBC) .
Q
Quchang Ouyang
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Hunan Cancer Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Yifei Chen, Binliang Liu, Zhanhong Chen...
https://pubmed.ncbi.nlm.nih.gov/42342669/Hunan Cancer Hospital
Lead Sponsor