This is a retrospective, single-arm real-world study based on the National Anticancer Drug Clinical Application Monitoring Network database.The aim of this study is to evaluate the efficacy and safety of paclitaxel liposome combined with anti-HER-2 monoclonal antibody as first-line salvage treatment for HER-2 positive advanced breast cancer. It seeks to understand the application patterns, efficacy, and safety of paclitaxel liposome combined with anti-HER-2 monoclonal antibody in real-world settings, providing patients with safer treatment options.
The National Anticancer Therapy Data Surveillance System (NATDSS) is the largest oncology diagnosis and treatment database in China to date, covering patient data from over 1400 oncology hospitals and integrated hospitals. It has collected data from approximately 15 million cancer patients since 2013, including mortality information obtained from the CDC death registration database. Paclitaxel liposome was introduced to the market in 2004 as a formulation of paclitaxel. It utilizes nanotechnology to encapsulate the poorly water-soluble paclitaxel within a lipid bilayer of liposomes, solving the issue of paclitaxel\& low solubility in water. Paclitaxel liposome no longer employs polyoxyethylated castor oil as a solvent. While ensuring efficacy, it reduces the risk of associated adverse drug reactions (such as severe allergic reactions), thereby enhancing the tolerance of cancer patients. Although paclitaxel liposome is widely used in HER-2 positive advanced breast cancer, there is currently no research on the efficacy and safety of combining paclitaxel liposome with anti-HER-2 monoclonal antibodies as first-line salvage treatment of HER-2 positive advanced breast cancer. This study aims to conduct a real-world study on the efficacy and safety of combining paclitaxel liposome with anti-HER-2 monoclonal antibodies as first-line salvage treatment of HER-2 positive advanced breast cancer based on the NATDSS
Study Type
OBSERVATIONAL
Enrollment
480
Paclitaxel liposome in combination with trastuzumab (or trastuzumab biosimilar, or pyrotinib) ± pertuzumab ± other chemotherapy drugs (such as capecitabine, carboplatin, gemcitabine) may be used for HER-2 positive patients, with the addition of endocrine therapy for triple-positive patients.
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Overall Survival (OS)
The time from the initiation of drug treatment until death due to any cause
Time frame: 5-year
real world progress free survival（rwPFS）
The time from the initiation of drug treatment until disease progression (as evaluated by medical records or imaging records) or death, whichever comes first, can be considered as the time to event endpoint in the study. This endpoint can be represented as the time to treatment change in case PFS data is missing.
Time frame: 5-year
Time To Progression
The time from the initiation of drug treatment until disease progression (as evaluated by medical records or imaging records)，Excluding death
Time frame: 5-year
Time to Treatment Failure
The time from the initiation of drug treatment until termination of treatment for any reason (including disease progression, unacceptable toxicity, and death)
Time frame: 5-year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.