RecruitingPhase 1Phase 2NCT06718933

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

A Prospective, Single-arm, Exploratory, Phase Ib/II Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis.


Sponsor

Fudan University

Enrollment

74 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — SHR-A1811 (an antibody-drug combination), pyrotinib (a targeted HER2 blocker), and bevacizumab (a drug that cuts off tumor blood supply) — in patients with advanced breast cancer that has spread to the brain. The goal is to see if this combination can treat brain tumors that have not yet been irradiated. **You may be eligible if...** - You are over 18 years old - You have breast cancer with brain metastases confirmed by MRI, with at least one measurable brain lesion - The brain tumors have not previously been treated with radiation - Your overall physical condition is adequate (ECOG 0-2) - Your life expectancy is at least 3 months - Your organ function and blood counts are adequate **You may NOT be eligible if...** - You have cancer that has spread to the membranes around the brain (leptomeningeal disease) - You have uncontrolled fluid buildup in body cavities (e.g., large amounts of fluid around the lungs) - You have brain complications that are not responding to treatment - You have rapidly progressing neurological symptoms or uncontrolled seizures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A1811

ADC

DRUGBevacizumab

bevacizumab biosimilar

DRUGPyrotinib

anti-HER2 inhibitor


Locations(1)

Fudan Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT06718933


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