Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer

Invasive Breast Cancer Clinical Trial

Official title:

Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05767931
• Other study ID #: BC-P32
• Status: Not yet recruiting
• Start date: March 6, 2023
• Est. completion date: March 6, 2025

Study information

• Verified date: February 2023
• Source: Peking University
• Contact: Zhaoqing Fan, MD
• Phone: +86-10-88197838
• Email: zhqfan[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, single-center, non-randomized, non-controlled study

Description:

Immunotherapy with immune-checkpoint inhibitors (ICIs) has enabled a leap forward in the treatment of various types of cancer within the past decade. However,only 12.46% of patients with cancer are expected to respond to ICIs.Our team have recently developed a multi-specific antibody technology platform for the microenvironment of solid tumors.

In this study, we are going to study the tumor immune microenvironment of breast cancer patients by patient-derived organoids or PDX model，to design multi-specific antibody drugs for different tumor immune microenvironment，to look forward to improve the effectiveness of immunotherapy for breast cancer and solve the problem of drug resistance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 6, 2025
• Est. primary completion date: November 6, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women between 18 and 70 years old;

2. Primary lesion >2cm on imaging examination, or suspected axillary lymph node metastasis on imaging examination;

3. Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments;

4. Subjects signed informed consent;

Exclusion Criteria:

1. A history of prior or concomitant malignancies;

2. Advanced stage breast cancer (stage IV);

3. Suspected or confirmed lesion was surgically removed;

4. Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.;

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antitumor rate of multi-specific antibody in patient-derived organoids and PDX model	Patient-derived organoids and PDX model	24 months