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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2026
  • participants needed
    200
  • sponsor
    Shengjing Hospital
Updated on 26 March 2022
cancer
carcinoma
breast cancer
carcinoma in situ
mastectomy
ductal carcinoma in situ
breast-conserving surgery
female breast cancer
ductal carcinoma
invasive carcinoma

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.

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.

Details
Condition Breast Neoplasms
Treatment Modified Radical Mastectomy, Expanded Mckissock surgery
Clinical Study IdentifierNCT04052893
SponsorShengjing Hospital
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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