The Detection of Cell-in-cell Structure (CICs) in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy

NCT ID: NCT05642104

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-10-01

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.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single group assignment

Patients with invasive breast cancer who need neoadjuvant therapy.

Neoadjuvant therapy

Intervention Type: DRUG

all procedures is in accordance with international guidelines and domestic expert consensus on breast cancer.

Interventions

Neoadjuvant therapy

all procedures is in accordance with international guidelines and domestic expert consensus on breast cancer.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongyan Huang, PHD

Role: PRINCIPAL_INVESTIGATOR

Beijing Shijitan Hospital, Capital Medical University

Locations

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongyan Huang, PHD

Role: CONTACT

hhongy1999@126.com

18911358631 ext. +86

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Other Identifiers

Z211100002921033

Identifier Type: -

Identifier Source: org_study_id