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

ConditionMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1811

    Drug

    SHR-A1811: intravenous

  • Pyrotinib

    Drug

    Pyrotinib: oral

  • Bevacizumab

    Drug

    Bevacizumab: intravenous

  • Adebelizumab

    Drug

    Adebelizumab: intravenous

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 2 interventions
Group C: Arm 3Experimental treatment 2 interventions
Group D: Arm 4Experimental treatment 1 intervention
Group E: Arm 5Experimental treatment 2 interventions
Group F: Arm 6Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

CNS-ORR by investigator

CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria

Time frame
2 months

Secondary outcomes

1

ORR by investigator using RECIST Guideline (Version 1.1)

ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1

Time frame
2 months
2

PFS

PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first

Time frame
up to 1.5 years
3

Adverse events

Proportion of participants experienced adverse events during the study period

Time frame
up to 1.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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