Breast Cancer Stage IV
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGfirst line treatment
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.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
1. Patients with unresectable or metastatic HER-2 positive breast cancer (immunohistochemistry 3+ or FISH positive) have received at least 2 cycles of salvage treatment with paclitaxel liposome in combination with anti-HER-2 therapy (monotherapy or dual-targeted therapy) ± other chemotherapy drugs (such as capecitabine, carboplatin, gemcitabine) as first-line treatment. 2. Patients with no visceral metastases, but only have bone metastases or multiple lymph node metastases are eligible for inclusion. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival of at least 3 months.
Exclusion criteria
： 1. Accompanied by other secondary malignant tumors. 2. Male breast cancer or bilateral breast cancer. 3. brain metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 5-year | The time from the initiation of drug treatment until death due to any cause |
| real world progress free survival（rwPFS） | 5-year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time To Progression | 5-year | The time from the initiation of drug treatment until disease progression (as evaluated by medical records or imaging records)，Excluding death |
| Time to Treatment Failure | 5-year | The time from the initiation of drug treatment until termination of treatment for any reason (including disease progression, unacceptable toxicity, and death) |
Countries
China
Outcome results
None listed