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Trial Title:
The Detection of Cell-in-cell Structure (CICs) in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy
NCT ID:
NCT05642104
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Neoplasms
cell-in-cell structures
Neoadjuvant therapy
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Neoadjuvant therapy
Description:
all procedures is in accordance with international guidelines and domestic expert
consensus on breast cancer.
Arm group label:
Single group assignment
Summary:
Breast cancer is the most common malignant tumor in women worldwide and neoadjuvant
therapy has been the standard care for local advanced breast cancer. Moreover,
neoadjuvant therapy undoubtedly provides an ideal model to evaluate the response to
therapy. Cell-in-cell structures (CICs) refer to the presence of one or more cells inside
host cell, which generally leads to the death of inner cells. Notably, established
evidences indicated that CICs were present in breast cancer and tend to impact patient
survival. However, whether CICs profile could predict efficacy of therapy remains
unclear. In this prospective cohort study, the CICs number and profile will be detected
in tumor tissue before and after the neoadjuvant therapy. Then the association between
CICs number including dynamic changing and response rate will be explored.
Criteria for eligibility:
Study pop:
Patients with breast cancer treated with neoadjuvant therapy attending Beijing Shijitan
Hospital from 2021-2023.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age 18-65, female;
- Pathological biopsy confirmed invasive ductal carcinoma;
- Karnofsky Performance Status (KPS)≥ 60, expected survival ≥4 months;
- Locally advanced breast cancer (HER2-positive disease and TNBC, ≥cT1c or ≥cN0；
HER2-negative，HR positive disease，≥cT2 or ≥cN1；Large primary tumor relative to
breast size in a patient who desires breast conservation) ;
- According to the RECIST1.1 standard, at least one measurable lesion exists;
Exclusion Criteria:
- Pregnant or lactating women;
- Left ventricular ejection fraction less than 50%;
- History of malignant tumor and concurrent occurrence of other tumors;
- Serious medical pathology, such as congestive heart failure; unstable angina;
uncontrolled high risk arrhythmias, and other serious illness or medical condition
that may interfere with the study;
- Refuse to participate in the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Shijitan Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100038
Country:
China
Status:
Recruiting
Start date:
October 1, 2021
Completion date:
October 1, 2024
Lead sponsor:
Agency:
Beijing Shijitan Hospital, Capital Medical University
Agency class:
Other
Source:
Beijing Shijitan Hospital, Capital Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05642104
