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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Beijing, China, 100021
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
inclusion criteria:
- 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.
- Patients with no visceral metastases, but only have bone metastases or multiple lymph node metastases are eligible for inclusion.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival of at least 3 months.
exclusion criteria：
- Accompanied by other secondary malignant tumors.
- Male breast cancer or bilateral breast cancer.
- brain metastasis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Survival (OS)
Time Frame: 5-year
|
The time from the initiation of drug treatment until death due to any cause
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5-year
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real world progress free survival（rwPFS）
Time Frame: 5-year
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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.
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5-year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time To Progression
Time Frame: 5-year
|
The time from the initiation of drug treatment until disease progression (as evaluated by medical records or imaging records)，Excluding death
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5-year
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Time to Treatment Failure
Time Frame: 5-year
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The time from the initiation of drug treatment until termination of treatment for any reason (including disease progression, unacceptable toxicity, and death)
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5-year
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Collaborators and Investigators
Investigators
- Study Chair: Zhou G Hui, MD, National Cancer Center/Cancer Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24/103-4383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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