NCT04385563 - A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC. | Biotech Hunter

Enrollment

338

Participants

Timeline

Start Date

November 11, 2018

Primary Completion Date

February 28, 2021

Study Completion Date

October 31, 2021

Conditions

HER2-positive Metastatic Breast Cancer

Interventions

DRUG

TQ-B211

Participants will receive TQ-B211 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.

DRUG

Herceptin®

Participants will receive Herceptin® 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.

DRUG

docetaxel

Participants will receive docetaxel 75 milligrams/square meter (mg/m\^2) iv.on day 2 in Cycle 1 followed by 75mg/m\^2 iv.on day 1 in Cycles 2 to 8.

Trial Locations (2)

150081

RECRUITING

Harbin Medical University Cancer Hospital, Harbin

200123

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai