Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor

NCT04626986 | Unknown DMC

• 1 other identifier: S2020-09
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Tumor; Microwave Ablation; Breast Conserving Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

microwave ablation

EXPERIMENTAL

Microwave ablation（MWA）refers to all electromagnetic methods of inducing tumor destruction by using devices with frequencies greater than or equal to 900MHz. The rotation of dipole molecules accounts for most of the heat generated during MWA. Water molecules as dipoles attempt to continuously reorient at the same rate in microwave's oscillating electric field. As a result of microwave transmission, the water molecules flip back and forth billions of times a second. The vigorous movement of water molecules produce friction and heat, thus inducing cellular death via coagulation necrosis. The microwave unit (KY-2000, Kangyou Medical, Nanjing, China) is capable of producing 100 Watts of power at 2450 MHz.The needle antenna has a diameter of 1.6 mm (16G) and a length of 10 cm. The active tip length is 3mm and 5mm.

Procedure: microwave ablation

breast conserving surgery

ACTIVE COMPARATOR

Breast-conserving surgery refers to the removal of the primary tumor and adjacent breast tissue, supplemented by postoperative radiotherapy.Its principle is to remove the primary tumor completely while meet patient's cosmetic satisfaction.The combined treatment of early breast cancer with radiotherapy and chemotherapy is the same as radical surgery or modified radical surgery in terms of local and regional control rate and long-term survival rate. Breast conserving surgery and postoperative comprehensive treatment have become one of the main methods for the treatment of early breast cancer.

Procedure: breast conserving surgery

Interventions

microwave ablation PROCEDURE

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.

microwave ablation

breast conserving surgery PROCEDURE

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.

breast conserving surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• men
• women who were pregnant or breastfeeding
• radiologic suspicion of multifocality or extensive intraductal carcinoma
• histologic diagnosis of lobular carcinoma
• neoadjuvant therapy
• previous surgery or radiation therapy of the ipsilateral breast.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Jie Yu, Dr.

CONTACT

66937981; jiemi301@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Professor

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: November 13, 2020
• Study Start: September 18, 2020
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

CN (1)