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Trial Title:
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy
NCT ID:
NCT05838001
Condition:
Breast Cancer
Breast-conserving Surgery
Conditions: Official terms:
Breast Neoplasms
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Wire-guided localization and marker clip localization
Description:
Positioning guide wire and marker clip in the center of the breast lesion
Arm group label:
patients after neoadjuvant therapy-combined localization
Intervention type:
Procedure
Intervention name:
marker clip localization
Description:
Positioning marker clip in the center of the breast lesion
Arm group label:
patients after neoadjuvant therapy-single localization
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. female patients, age≥18 year
2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
3. Patients pathologically diagnosed with breast cancer by core-needle biopsy, received
neoadjuvant treatment and the lesion becomes non-palpable before enrollment.
4. Patients are willing to undergo breast conserving surgery and have no
contraindications to breast conserving surgery
Exclusion Criteria:
1. Inflammatory breast cancer or Paget's disease
2. Breast deformities and other conditions that impact breast conservation success rate
3. 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.
4. Pregnancy or lactation
5. Patients with hook-wire, radioactive 125I seed or other localization techniques in
the breast cancer lesions before enrollment
6. Patients with stage IV diseases or unresectable lesions in either breast
7. Patients combined with other diseases that may affect survival
8. Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on
imaging examinations
9. Patients who have previously undergone radical mastectomy for ipsilateral breast
cancer or chest wall radiotherapy
10. Patients with history of ipsilateral breast cancer radical mastectomy or chest wall
radiotherapy
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Chang Gong, doctor
Phone:
02034070499
Email:
changgong282@163.com
Start date:
February 16, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05838001
