NCT04185649

The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer

A Clinical Study Evaluating the Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer - A Multicenter, Randomized, Open-label, Positive-controlled, Superiority Phase III Clinical Trial in China

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.

Detailed description

This is a multicenter, randomized, open-label, positive-controlled, superiority phase III clinical study. The object is to evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug. Eligible subjects will be randomized to the experimental or control group in a 1:1 ratio and stratified by the number of HER2-positive advanced/metastatic breast cancer treatment regimens (0, 1 VS \> 1) and lesion site (organ VS non-organ).

Conditions

• HER2-positive Advanced Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BAT8001 for injection	3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.
DRUG	Lapatinib	Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
DRUG	Capecitabine	Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-07-31
• Completion: 2021-12-31
• First posted: 2019-12-04
• Last updated: 2019-12-04

Locations

51 sites across 1 country: China