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

Overview

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.

Interventions

• Procedure Expanded Mckissock surgery
  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
• Procedure Modified radical mastectomy
  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.

Primary outcome measures

• Disease-free survival. [Time frame: 5 years]

Secondary outcome measures (3)

• European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23) scale [Time frame: 5 years]
• Breast symmetry [Time frame: 5 years]
• Medical cost [Time frame: During hospitalization, an average of 2 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 3 centers

• General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group — Benxi
• Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute — Shengyang
• Shengjing Hospital of China Medical University — Shenyang

Identifiers

NCT: NCT04052893 · Shengjing-LJY02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗