Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor

Breast Tumor Clinical Trial

Official title:

Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Breast Conserving Surgery for Breast Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626986
• Other study ID #: S2020-09
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2021
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Dr.
• Phone: 66937981
• Email: jiemi301[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Conserving Surgery
• Breast Neoplasms
• Breast Tumor
• Microwave Ablation

Intervention

Procedure:
• microwave ablation
Microwave ablation has the advantages of aesthetics, precise positioning, minimally invasive and painless for patients with early breast cancer.The tumor can be completely killed without injurying adjacent tissue. Some studies have suggested MWA is a safe and effective therapy for the treatment of breast cancer.
• breast conserving surgery
The treatment of early-stage breast cancer tends to be less-invasive including less morbidity, shorter hospitalization, and improved cosmetic results. Many reports have concluded that there was no difference between breast-conserving surgery and the traditional radical mastectomy for early stage breast cancer in time to distant metastases or overall survival, so breast-conserving surgery is becoming an alternative treatment for early-stage breast cancer.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival:Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)	Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)	5 years
Primary	cosmetic satisfaction:Patients are rated whether they are satisfied with the surgical scars(bad / moderate /good / very good)	Patients are rated whether they are satisfied with the surgical scars(bad / moderate /good / very good)	3 years
Secondary	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	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	5 years
Secondary	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	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
Secondary	complication:Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient	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