Overview

A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients

Status:
Completed

Trial end date:
2017-12-01

Target enrollment:

Participant gender:

Summary

BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes pharmacokinetics assessment.

Phase:

Phase 3

Details

Lead Sponsor:

Biocad

Treatments:

Albumin-Bound Paclitaxel
Paclitaxel
Trastuzumab