Clinical trial · Observational
RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody
Real-world Study of the Efficacy and Safety of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody as First-line Salvage Treatment of HER-2 Positive Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| first line treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- 5-year
- description
- The time from the initiation of drug treatment until death due to any cause
- measure
- real world progress free survival（rwPFS）
- timeFrame
- 5-year
- description
- 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 outcomes (2)
- measure
- Time To Progression
- timeFrame
- 5-year
- description
- The time from the initiation of drug treatment until disease progression (as evaluated by medical records or imaging records)，Excluding death
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available