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

Recruiting

• Conditions: Breast Neoplasms
• Interventions: Drug: Neoadjuvant therapy

• Registration Number: NCT05642104
• Lead Sponsor: Beijing Shijitan Hospital, Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Study First Posted: 2022-12-08
• Last Update Posted: 2022-12-08
• Primary Completion: 2023-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 175

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group assignment	Neoadjuvant therapy	Patients with invasive breast cancer who need neoadjuvant therapy.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 24 weeks.	Response Evaluation Criteria in Solid Tumors (RECIST)：Progressive Disease (PD); Partial Response (PR); Complete Response (CR); Stable Disease (SD) Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) partial response (PR) to treatment.
pCR(complete pathological response)	Up to 24 weeks.	no invasive malignant cells identifiable in sections from the site of the tumor（Miller-Payne grades 5） the Miller-Payne grades 4 and 5 patients are grouped as responders.
Quantification of CIC structure in tumor tissue	Up to 24 weeks.	CICs number and subtypes in tumor tissue (Core needle biopsy specimens before and after neoadjuvant therapy and surgical specimens based on neoadjuvant therapy.)

Trial Locations

Locations (1)

Beijing Shijitan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China