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A Multi-cohort Phase II Study of HER2-positive and Triple-negative Breast Cancer Brain Metastases.

Breast Cancer Clinical Trial

Official title:
A Prospective, Single-arm, Single-center, Multi-cohort Phase II Clinical Study of HER2-positive and Triple-negative Breast Cancer Brain Metastases

Clinical Trial Summary

The study is being conducted to assess the effectiveness and safety of treatment options for breast cancer brain metastases based on molecular typing.

Clinical Trial Description

This is a prospective, single-arm, single-center, two cohorts, Simon's two-stage design, phase II clinical trial in HER2-positive and triple-negative breast cancer brain metastases patients. Subjects will be divided into two cohorts by hormone receptor status and HER2 status. HER2+/HR- subjects will enter Cohort A to receive pyrotinib plus temozolomide; HER2-/HR- subjects will enter Cohort B to receive bevacizumab, SHR1316 combined with cisplatin/carboplatin. Subjects in both cohorts will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, and investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04303988
Study type Interventional
Source Fudan University
Contact Zhang Jian
Phone 13918273761
Email syner2000@163.com
Status Not yet recruiting
Phase Phase 2
Start date March 30, 2020
Completion date January 30, 2022
View Details
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