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

NCT04185649 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2019-12-04

No results posted yet for this study

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.

Conditions

  • HER2-positive Advanced Breast Cancer

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Shusen Wang, M.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2020-07-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04185649 on ClinicalTrials.gov