SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases

Phase 2

Not yet recruiting

• Conditions: Breasr Cancer
• Interventions: Drug: SHR-A1811; Drug: Bevacizumab

• Registration Number: NCT06361979
• Lead Sponsor: Huihua Xiong

Brief Summary

This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Study Start: 2024-05
• Primary Completion: 2025-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. ≥18 years old;
2. Pathologically confirmed HER2-positive breast cancer;
3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
4. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed.
5. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
6. Adequate function of major organs-

Exclusion Criteria

1. 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;

2. Previous treatment with bevacizumab;

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

4. History of clinically significant lung disease；

5. 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.

6. 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.).

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM1	SHR-A1811	-
ARM1	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
CNS-ORR	Up to 2 years	CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria

Secondary Outcome Measures

Name	Time	Method
AE	Up to 2 years	Proportion of participants experienced adverse events during the study period
PFS	up to 2 years	PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first
ORR	Up to 2 years	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