SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases

NCT06975475 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-16

No results posted yet for this study

Summary

The aim of this project is to evaluate whether the sequence of Trastuzumab,pyrotinib and Nab-Paclitaxel in first line followed by SHR-A1811 in second line is superior to the sequence of SHR-A1811 in first line followed by Trastuzumab,pyrotinib and Nab-Paclitaxel in second line for HER2 positive breast cancer brain metastases.

Conditions

Interventions

DRUG

SHR-A1811,tratuzumab,pyrotinib,Nab-Paclitaxel

SHR-A1811:4.8mg/kg tratuzumab:Initial 8mg/kg followed by 6mg/kg pyrotinib:320mg Nab-Paclitaxel:100-150mg/m2

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-06-01
Completion
2028-06-01

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Entities

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 NCT06975475 on ClinicalTrials.gov