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

Peking University

Status: Not yet enrolling

Conditions: Invasive Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05767931

BC-P32

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.；