Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor

Not Applicable

• Conditions: Breast Tumor; Breast Conserving Surgery; Microwave Ablation

• Registration Number: NCT04626986
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance.

Detailed Description

A total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent US-guided percutaneous MWA and breast conserving surgery treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.

Study Timeline

• Study Start: 2020-09-18
• Study First Submitted: 2020-09-27
• Study First Submitted QC: 2020-11-08
• Study First Posted: 2020-11-13
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-26
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. women,
2. with invasive ductal carcinoma of the breast according to core-needle
3. tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 )
4. located at least 10 mm from the skin surface and chest wall.

Exclusion Criteria

1. men
2. women who were pregnant or breastfeeding
3. radiologic suspicion of multifocality or extensive intraductal carcinoma
4. histologic diagnosis of lobular carcinoma
5. neoadjuvant therapy
6. previous surgery or radiation therapy of the ipsilateral breast.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)	5 years	Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）	3 years	Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）

Secondary Outcome Measures

Name	Time	Method
local tumor progress：Defined as the proportion of patients with active tumor at the edge of the treatment ：Defined as the proportion of patients with active tumor at the edge of the treatment	5 years	Defined as the proportion of patients with active tumor at the edge of the treatment area during follow-up after the tumor was completely treated
metastasis：Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient	5 years	Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient	5 years	Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China