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Recruiting NCT05769010

Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

Phase II Interventional Metastatic Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-A1811, Pyrotinib, Bevacizumab, Adebelizumab.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

Overview

This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.

Interventions

  • Drug SHR-A1811
    SHR-A1811: intravenous
  • Drug Pyrotinib
    Pyrotinib: oral
  • Drug Bevacizumab
    Bevacizumab: intravenous
  • Drug Adebelizumab
    Adebelizumab: intravenous

Primary outcome measures

  • CNS-ORR by investigator [Time frame: 2 months]
Secondary outcome measures (3)
  • ORR by investigator using RECIST Guideline (Version 1.1) [Time frame: 2 months]
  • PFS [Time frame: up to 1.5 years]
  • Adverse events [Time frame: up to 1.5 years]

Eligibility criteria

Inclusion criteria

  • Females and males ≥18 yrs old;
  • Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
  • At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
  • Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
  • More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. Patients with HER2-Low disease must not have systemic treatment for brain metastases.
  • Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
  • Life expectancy is not less than 6 months.
  • Adequate function of major organs.

Exclusion criteria

  • Leptomeningeal involvement;
  • CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;
  • Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
  • Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed on previous bevacizumab therapy were excluded from Arm 3 and Arm 5 ,and Arm 6 excludes patients who have progressed on prior PD-1 or PD-L1 therapy;
  • No concurrent antitumor therapy for metastatic cancer other than the study treatment;
  • Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment;
  • Participated in other drug clinical trials within 4 weeks before admission;
  • History of clinically significant lung disease；
  • Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
  • According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
  • Any other conditions that researchers believe that patients are unsuitable for this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Henan Cancer Hospital — Zhengzhou

Identifiers

NCT: NCT05769010 · HNCH-MBC12 · HNCH-MBC12-BM04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗