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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769010
• Other study ID #: HNCH-MBC12
• Secondary ID: HNCH-MBC12-BM04
• Status: Recruiting
• Phase: Phase 2
• Start date: March 31, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: October 2023
• Source: Henan Cancer Hospital
• Contact: Min Yan, Professor
• Phone: +86 15713857388
• Email: ym200678[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2026
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Females =18 yrs old;

2. Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;

3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;

4. Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;

5. 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.

6. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;

7. Life expectancy is not less than 6 months.

8. Adequate function of major organs.

Exclusion Criteria:

1. Leptomeningeal involvement;

2. CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;

3. 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;

4. 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;

5. No concurrent antitumor therapy for metastatic cancer other than the study treatment;

6. Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment;

7. Participated in other drug clinical trials within 4 weeks before admission;

8. History of clinically significant lung disease;

9. 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.

10. 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.).

11. Any other conditions that researchers believe that patients are unsuitable for this study.

Related Conditions & MeSH terms

• Brain Neoplasms
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CNS-ORR by investigator	CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria	2 months
Secondary	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	2 months
Secondary	PFS	PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first	up to 1.5 years
Secondary	Adverse events	Proportion of participants experienced adverse events during the study period	up to 1.5 years