Clinical trial NCT04626986: Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor
Official title: Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Breast Conserving Surgery for Breast Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Tumor
Microwave Ablation
Breast Conserving Surgery
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
timeFrame: 5 years
measure: cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
timeFrame: 3 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: