RecruitingPhase 2

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

China150 participantsStarted 2023-03-31

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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；

CNS-ORR by investigator

Timeframe: 2 months

NCT IDNCT05769010

SponsorHenan Cancer Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-12-30

Min Yan, Professor

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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；