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Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis

NCT06718933 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-02-06

No results posted yet for this study

Summary

In phase Ib, our study is aimed to evaluate the safety and tolerance of SHR-A1811 combined with pyrotinib in breast cancer with brain metastasis, and confirm the recommended phase 2 dose combined with preliminary results of efficacy.

In phase II, our study is aimed to evaluate the efficacy and safety of SHR-A1811 combined with pyrotinib and bevacizumab at RP2D in breast cancer with brain metastasis.

Conditions

  • Breast Cancer Metastatic
  • Breast Cancer Brain Metastases

Interventions

DRUG

SHR-A1811

ADC

DRUG

Bevacizumab

bevacizumab biosimilar

DRUG

Pyrotinib

anti-HER2 inhibitor

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Hongxia Wang, Chief physician · Fudan University

  • Biyun Wang, Chief physician · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2026-08-31
Completion
2027-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06718933 on ClinicalTrials.gov