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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer Stage IV
• Intervention / Treatment: Drug: first line 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: Observational
• Enrollment (Estimated): 480

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time To Progression	The time from the initiation of drug treatment until disease progression (as evaluated by medical records or imaging records)，Excluding death	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)	5-year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Chair: Zhou G Hui, MD, National Cancer Center/Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 24/103-4383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No