A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

474

Participants

Timeline

Start Date

April 29, 2020

Primary Completion Date

December 31, 2022

Study Completion Date

April 13, 2023

Conditions
Breast Cancer
Interventions
DRUG

QL1701

8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.

DRUG

Herceptin®

8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.

DRUG

Docetaxel

The recommended dose is 75mg/m2 and the infusion time is approximately 70min (±20min) (or adjusted according to clinical experience at each study center). The drug was administered once every 3 weeks for a treatment cycle of 3 weeks, with the exception of the second day of the first cycle, followed by the first day of each cycle for at least 8 cycles

Trial Locations (1)

Unknown

Cancer Hospital,Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

NCT05629949 - A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter