DFS and QOL After Modified Radical Mastectomy vs. Expanded Mckissock Surgery for EIC of the Breast

NCT04052893 | Recruiting DMC

• 1 other identifier: Shengjing-LJY02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Extensive intraductal carcinoma of the breast refers to a type of breast cancer in which ≥ 25% of ductal carcinoma in situ is present in invasive tumors and there is a scattered distribution of ductal carcinoma in situ (DCIS) in or around the invasive carcinoma. Compared with DCIS negative for extensive intraductal component, DCIS positive for extensive intraductal component is not sensitive to radiotherapy. Mckissock surgery was applied in breast-conserving surgery for breast cancer in 2016. Jianyi Li and the team members (Shengjing Hospital of China Medical University, Shenyang, China) applied this technique in breast-conserving surgery with preservation of the nipple-areola complex. This surgical technique is suitable for low-grade malignant tumors and has better prognosis than radical mastectomy. The purpose of this study is to investigate postoperative disease-free survival and quality of life after modified radical mastectomy versus expanded Mckissock surgery for extensive intraductal carcinoma of the breast. Results from this study will indicate the efficacy of expanded Mckissock surgery in the treatment of extensive intraducatal carcinoma of the breast.

Conditions

Breast Neoplasms

Keywords

Surgery; Plastic

Outcome Measures

Primary Outcomes (1)

• Disease-free survival.

  Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.

  5 years

Secondary Outcomes (3)

• European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23) scale

  5 years

• Breast symmetry

  5 years

• Medical cost

  During hospitalization, an average of 2 weeks

Study Arms (2)

Study group

EXPERIMENTAL

100 patients will be assigned into a study group.

Procedure: Expanded Mckissock surgery

Control group

ACTIVE COMPARATOR

100 patients will be assigned into a control group.

Procedure: Modified radical mastectomy

Interventions

Expanded Mckissock surgery PROCEDURE

Expanded Mckissock surgery: (1) According to patient's preoperative imaging results and subjective expectations of their own breast morphology, the incision design and breast surface marking will be performed under the standing position. (2) After general anesthesia, the upper limbs will be abducted, and the upper body will be tilted by 15°-20° to dermatize the labeled skin around and below the areola. (3) The medial and lateral flaps will be dissociated to remove the total gland with nipple and areola preserved. (4) The cutting-edge of nipple-areola complex will be sent for cancer screening. The axillary lymph node biopsy or cleaning will be performed along the outer edge of the pectoralis major muscle. (5) The vertical subcutaneous pedicle flaps will be W-folded, and the flaps on both sides will be pulled to the vertical pedicle to reshape the breast. During this process, the breast and armpit drainage tubes will be indwelled.

Study group

Modified radical mastectomy PROCEDURE

The patients will be placed in the supine position. After intravenous anesthesia, the tumor boundary will be marked and the breast will be removed. The vertical subcutaneous pedicle flaps will be W-folded, and the flaps on both sides will be pulled to the vertical pedicle to reshape the breast. During this process, the breast and armpit drainage tubes will be indwelled.

Control group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with extensive intraductal carcinoma confirmed by hollow needle biopsy;
• the lesion not involving the nipple as confirmed by enhanced MR imaging of the breast;
• Bra cup size: B or higher;
• postmenopausal patients;
• provision of written informed consent.

You may not qualify if:

• The cutting edge of nipple-areola complex tested positive for extensive intraductal carcinoma twice;
• preoperative nipple hemorrhage;
• bilateral breast cancer;
• inflammatory breast cancer;
• distant metastasis;
• other cancers or those who receive chest radiotherapy.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (3)

General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group

Benxi, Liaoning, 117000, China

RECRUITING

Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute

Shengyang, Liaoning, 110042, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Modified Radical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mastectomy, Radical; Mastectomy; Surgical Procedures, Operative

Study Officials

• Jianyi Li

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianyi Li

CONTACT

+8618940257177; sjbreast@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 12, 2019
• Study Start: October 1, 2019
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

CN (3)