Clinical trial NCT05642104: The Detection of Cell-in-cell Structure (CICs) in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy
Official title: The Detection of Cell-in-cell Structure (CICs) in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: Breast Neoplasms
cell-in-cell structures
Neoadjuvant therapy
Lead sponsor: Beijing Shijitan Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer treated with neoadjuvant therapy attending Beijing Shijitan Hospital from 2021-2023.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: pCR(complete pathological response)
timeFrame: Up to 24 weeks.
measure: Objective response rate (ORR)
timeFrame: Up to 24 weeks.
measure: Quantification of CIC structure in tumor tissue
timeFrame: Up to 24 weeks.
Secondary outcomes:
Other outcomes:
measure: Disease-free survival (DFS)
timeFrame: Within 5 years after surgery
measure: Overall survival (OS)
timeFrame: Within 10 years after surgery
measure: CEA(carcinoembryonic antigen)
timeFrame: Up to 24 weeks.
measure: CA125(Carbohydrate antigen125)
timeFrame: Up to 24 weeks.
measure: CA199(Carbohydrate antigen199)
timeFrame: Up to 24 weeks.
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Shijitan Hospital, Capital Medical University
name: Hongyan Huang, PHD
role: PRINCIPAL_INVESTIGATOR
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