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Trial Title:
Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer
NCT ID:
NCT05767931
Condition:
Invasive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
This is a prospective, single-center, non-randomized, non-controlled study
Detailed 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.
Criteria for eligibility:
Study pop:
invasive breast cancer
Sampling method:
Non-Probability Sample
Criteria:
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.；
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Contact:
Last name:
Zhaoqing Fan
Phone:
+86-10-88197838
Email:
zhqfan@sina.com
Investigator:
Last name:
Zhaoqing Fan, MD
Email:
Principal Investigator
Investigator:
Last name:
Zhaorong Guo, PhD
Email:
Sub-Investigator
Start date:
March 6, 2023
Completion date:
March 6, 2025
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05767931
