Clinical trial · Interventional
DFS and QOL After Modified Radical Mastectomy vs. Expanded Mckissock Surgery for EIC of the Breast
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expanded Mckissock surgery | Procedure | — | UNRESOLVED |
| Modified radical mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study group
- description
- 100 patients will be assigned into a study group.
- interventionNames
- Procedure: Expanded Mckissock surgery
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- 100 patients will be assigned into a control group.
- interventionNames
- Procedure: Modified radical mastectomy
Primary outcomes (1)
- measure
- Disease-free survival.
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available