Clinical trial NCT04052893: DFS and QOL After Modified Radical Mastectomy vs. Expanded Mckissock Surgery for EIC of the Breast
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Keywords: Surgery
Plastic
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival.
timeFrame: 5 years
Secondary outcomes:
measure: European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23) scale
timeFrame: 5 years
measure: Breast symmetry
timeFrame: 5 years
measure: Medical cost
timeFrame: During hospitalization, an average of 2 weeks
Other outcomes:
Locations:
city: Benxi
country: China
facility: General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group
state: Liaoning
city: Shengyang
country: China
facility: Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Jianyi Li
role: PRINCIPAL_INVESTIGATOR
References: