Study Comparing Safety and Effectiveness of QL0605 Injections Given 24 or 48 Hours After Chemotherapy in Breast Cancer Patients

What this Trial Is About

This research aims to compare the effectiveness and safety of QL0605 injections given at two different times after chemotherapy in patients with invasive breast cancer. The study focuses on patients scheduled for at least two cycles of specific chemotherapy regimens TACTCTCbH and evaluates the prevention of febrile neutropenia and other related side effects. It is a multicenter, open-label, randomized phase 4 trial sponsored by Qilu Pharmaceutical Co., Ltd. Patients are randomly assigned in a 21 ratio to receive QL0605 injections subcutaneously either 24 hours or 48 hours after each chemotherapy cycle. Each participant is planned to receive two chemotherapy cycles spaced three weeks apart. The primary comparison is the rate of febrile neutropenia during the first chemotherapy cycle, with secondary assessments including severe neutropenia, chemotherapy dose changes, delays caused by neutropenia, antibiotic use, and pain related to bones, muscles, or joints. Participants will be closely monitored throughout each chemotherapy cycle with assessments of their blood counts and clinical status to detect febrile neutropenia and other adverse events. The main outcome measured is the incidence of febrile neutropenia during the first 21-day chemotherapy cycle. The study includes safety monitoring and follow-up during and after treatment, with total involvement lasting through the two chemotherapy cycles and associated assessments.

Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints