drugset / Trial / NCT05420467

A Study for the Adjuvant Treatment of Breast Cancer

NCT05420467

RandomizedParallel-groupOpen-labelTreatment

Summary

Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.

Timeline

Start
2022-07-10
Primary completion
2027-07-10
Completion
2027-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2
Comparator Docetaxel Small molecule 75 mg/m2
Comparator Docetaxel Small molecule 100 mg/m2
Subject Epirubicin Small molecule 90 mg/m2
Subject Paclitaxel Small molecule 125 mg/m2
Subject Paclitaxel Small molecule 220 mg/m2
Background Carboplatin Small molecule 6 unknown
Background Pertuzumab Monoclonal antibody 420 mg
Background Trastuzumab Monoclonal antibody 6 mg/kg

Indications