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

NCT06361979 | Not Yet Recruiting Phase 2

• 1 other identifier: A1811
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• CNS-ORR

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

  Up to 2 years

Secondary Outcomes (3)

• PFS

  up to 2 years

• ORR

  Up to 2 years

• AE

  Up to 2 years

Study Arms (1)

ARM1

EXPERIMENTAL

Drug: SHR-A1811; Drug: Bevacizumab

Interventions

SHR-A1811 DRUG

SHR-A1811: intravenous

ARM1

Bevacizumab DRUG

Bevacizumab:intravenous

ARM1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old;
• Pathologically confirmed HER2-positive breast cancer;
• At least one measurable intracranial lesion according to RANO-BM criteria, which had not received 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.
• Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
• Adequate function of major organs-

You may not qualify if:

• 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;
• Previous treatment with bevacizumab;
• Participated in other drug clinical trials within 4 weeks before admission;
• History of clinically significant lung disease；
• 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.
• 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.).
• Any other conditions that researchers believe that patients are unsuitable for this study.

Sponsors & Collaborators

• Huihua Xiong: lead

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiong huihua

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiong huihua

CONTACT

13886073988; xionghuihua@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04