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

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
Wire-guided 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 untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization 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 hookwire, 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

Sites / Locations

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Untreated patients-combined localization

Untreated patients-single localization

Arm Description

In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation

In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation

Outcomes

Primary Outcome Measures

positive margin rate
It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis.

Secondary Outcome Measures

Re-operation rate
the proportion of patients which have a positive margin and requires reoperation
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
February 26, 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
NCT05797454
Brief Title
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer
Official Title
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer: 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 preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
Detailed Description
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization. This study aims to compare the accuracy and efficacy of wire 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
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Untreated patients-combined localization
Arm Type
Experimental
Arm Description
In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation
Arm Title
Untreated patients-single localization
Arm Type
Active Comparator
Arm Description
In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation
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 lesion
Intervention Type
Procedure
Intervention Name(s)
Wire-guided localization
Intervention Description
Positioning guide wire in the center of the lesion
Primary Outcome Measure Information:
Title
positive margin rate
Description
It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis.
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 reoperation
Time Frame
up to 3 months after first operation
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 after first operation
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 untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization 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 hookwire, 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
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 Memorial Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gong Chang, doctor
Phone
02034070499
Email
changgong282@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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