Clinical trial NCT05797454: 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
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast-conserving Surgery
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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
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 hookwire, 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

Primary outcomes:
measure: positive margin rate
timeFrame: up to 3 months
Secondary outcomes:
measure: Re-operation rate
timeFrame: up to 3 months after first operation
measure: The proportion of breast-conserving surgery
timeFrame: up to 3 months after first operation
measure: IDFS
timeFrame: 2 years, 3 years, and 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: