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Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy

Primary Purpose

Breast Cancer, Breast-conserving Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Wire-guided localization and marker clip localization
marker clip localization
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: female patients, age≥18 year A score of ≥ 2 on the Eastern Cooperative Oncology Group scale Patients pathologically diagnosed with breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery Exclusion Criteria: Inflammatory breast cancer or Paget's disease Breast deformities and other conditions that impact breast conservation success rate Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded. Pregnancy or lactation Patients with hook-wire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment Patients with stage IV diseases or unresectable lesions in either breast Patients combined with other diseases that may affect survival Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on imaging examinations Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy Patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy

Sites / Locations

  • Sun Yat-sen University Sun Yat-sen Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients after neoadjuvant therapy-combined localization

patients after neoadjuvant therapy-single localization

Arm Description

Outcomes

Primary Outcome Measures

Marginal positive rate
Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer)

Secondary Outcome Measures

Re-operation rate.
the proportion of patients which have a positive margin and requires a re-operation
The proportion of breast-conserving surgery.
It refers to the proportion of patients who have successfully undergone breast-conserving surgery.
IDFS
Time from surgery to the first occurrence of local, distant disease recurrence, or death.

Full Information

First Posted
April 2, 2023
Last Updated
April 20, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05838001
Brief Title
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy
Official Title
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy : a Prospective Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The standard method for localizing non-palpable breast cancer is currently clip localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of single vs. combined breast tissue markers in localizing non-palpable breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast-conserving Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients after neoadjuvant therapy-combined localization
Arm Type
Experimental
Arm Title
patients after neoadjuvant therapy-single localization
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Wire-guided localization and marker clip localization
Intervention Description
Positioning guide wire and marker clip in the center of the breast lesion
Intervention Type
Procedure
Intervention Name(s)
marker clip localization
Intervention Description
Positioning marker clip in the center of the breast lesion
Primary Outcome Measure Information:
Title
Marginal positive rate
Description
Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer)
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Re-operation rate.
Description
the proportion of patients which have a positive margin and requires a re-operation
Time Frame
up to 3 months
Title
The proportion of breast-conserving surgery.
Description
It refers to the proportion of patients who have successfully undergone breast-conserving surgery.
Time Frame
up to 3 months
Title
IDFS
Description
Time from surgery to the first occurrence of local, distant disease recurrence, or death.
Time Frame
2 years, 3 years, and 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female patients, age≥18 year A score of ≥ 2 on the Eastern Cooperative Oncology Group scale Patients pathologically diagnosed with breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery Exclusion Criteria: Inflammatory breast cancer or Paget's disease Breast deformities and other conditions that impact breast conservation success rate Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded. Pregnancy or lactation Patients with hook-wire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment Patients with stage IV diseases or unresectable lesions in either breast Patients combined with other diseases that may affect survival Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on imaging examinations Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy Patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Gong, doctor
Phone
02034070499
Email
changgong282@163.com
Facility Information:
Facility Name
Sun Yat-sen University Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Gong, doctor
Phone
02034070499
Email
changgong282@163.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy

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