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

> **NCT04185649** · PHASE3 · UNKNOWN · sponsor: **Bio-Thera Solutions** · enrollment: 410 (estimated)

## Conditions studied

- HER2-positive Advanced Breast Cancer

## Interventions

- **BIOLOGICAL:** BAT8001 for injection
- **DRUG:** Lapatinib
- **DRUG:** Capecitabine

## Key facts

- **NCT ID:** NCT04185649
- **Lead sponsor:** Bio-Thera Solutions
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** UNKNOWN
- **Start date:** 2018-07-01
- **Primary completion:** 2020-07-31
- **Final completion:** 2021-12-31
- **Target enrollment:** 410 (ESTIMATED)
- **Last updated:** 2019-12-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04185649

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04185649, "The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT04185649. Licensed CC0.

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