RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody

NCT06481553 | Active Not Recruiting

• 1 other identifier: 24/103-4383
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Stage IV

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  The time from the initiation of drug treatment until death due to any cause

  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.

  5-year

Secondary Outcomes (2)

• Time To Progression

  5-year

• Time to Treatment Failure

  5-year

Interventions

first line treatment DRUG

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival of at least 3 months.

You may not qualify if:

• Accompanied by other secondary malignant tumors.
• Male breast cancer or bilateral breast cancer.
• brain metastasis

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhou G Hui, MD

  National Cancer Center/Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: February 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)