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

NCT ID: NCT06361979

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2026-05-31

Brief Summary

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

Conditions

Breasr Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM1

Group Type: EXPERIMENTAL

SHR-A1811

Intervention Type: DRUG

SHR-A1811: intravenous

Bevacizumab

Intervention Type: DRUG

Bevacizumab:intravenous

Interventions

SHR-A1811

SHR-A1811: intravenous

Intervention Type: DRUG

Bevacizumab

Bevacizumab:intravenous

Intervention Type: DRUG

Eligibility Criteria

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.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huihua Xiong

OTHER

Sponsor Role: lead

Responsible Party

Huihua Xiong

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiong huihua

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology

Central Contacts

Xiong huihua

Role: CONTACT

xionghuihua@hotmail.com

13886073988

Other Identifiers

A1811

Identifier Type: -

Identifier Source: org_study_id