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

Breast Neoplasms Clinical Trial

Official title: Postoperative Disease-free Survival and Quality of Life After Modified Radical Mastectomy Versus Expanded Mckissock Surgery for Extensive Intraductal Carcinoma of the Breast: a Prospective Cohort Study Protocol

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. Studies have shown that patients with DCIS positive for extensive intraductal component have more residual tumors than patients with DCIS negative for extensive intraductal component. There are still many subclinical tumors in the residual mammary gland after removal of the main invasive tumor foci. This provides the condition for tumor recurrence after breast-conserving surgery, and the risk of tumor recurrence in DCIS positive for extensive intraductal component is 2.52 times that in DCIS negative for extensive intraductal component. Compared with DCIS negative for extensive intraductal component, DCIS positive for extensive intraductal component is not sensitive to radiotherapy.

Mckissock surgery is originated from a breast reduction surgery developed by American doctors in 1970, which can remove glands to the maximum extent. This technique was applied to breast-conserving surgery in 2016, which initiated the application of this operation in malignant tumors. Jianyi Li and the team members (Shengjing Hospital of China Medical University, Shenyang, China) first applied expanded Mckissock surgery in breast-conserving surgery with the nipple-areola complex preserved. This surgical technique is suitable for low-grade malignant tumors. This surgical technique has been performed in 30 patients and results showed that the expanded Mckissock surgery has better prognosis than radical mastectomy. Therefore, this prospective cohort study will compare the postoperative disease-free survival and quality of life between modified radical mastectomy and expanded Mckissock surgery. ;

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT04052893
• Study type: Interventional
• Source: Shengjing Hospital
• Contact: Jianyi Li
• Phone: +8618940257177
• Email: sjbreast@yeah.net
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Completion date: September 1, 2026