Comparing two surgical methods for extensive intraductal carcinoma 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
NA · Shengjing Hospital · NCT04052893
This study is testing which of two surgical methods, modified radical mastectomy or expanded Mckissock surgery, helps women with extensive intraductal carcinoma of the breast live better and longer after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Female |
| Sponsor | Shengjing Hospital (other) |
| Locations | 3 sites (Benxi, Liaoning and 2 other locations) |
| Trial ID | NCT04052893 on ClinicalTrials.gov |
What this trial studies
This study investigates the outcomes of two surgical approaches for treating extensive intraductal carcinoma of the breast: modified radical mastectomy and expanded Mckissock surgery. The focus is on postoperative disease-free survival and quality of life for patients undergoing these procedures. The expanded Mckissock surgery aims to preserve the nipple-areola complex while effectively removing cancerous tissue. The study is being conducted at multiple hospitals in Liaoning, China, with a specific focus on patients with low-grade malignant tumors.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women with extensive intraductal carcinoma confirmed by biopsy and without nipple involvement.
Not a fit: Patients with inflammatory breast cancer, distant metastasis, or those who have had prior chest radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into better surgical options that improve survival rates and quality of life for patients with extensive intraductal carcinoma.
How similar studies have performed: While the Mckissock surgery has been applied in breast-conserving surgery, this specific comparison of surgical techniques for extensive intraductal carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Benxi, Liaoning and 2 other locations
- General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group — Benxi, Liaoning, China (RECRUITING)
- Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute — Shengyang, Liaoning, China (RECRUITING)
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
Study contacts
- Principal investigator: Jianyi Li — Shengjing Hospital
- Study coordinator: Jianyi Li
- Email: sjbreast@yeah.net
- Phone: +8618940257177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Neoplasms, Surgery, Plastic