NCT04052893 DFS and QOL After Modified Radical Mastectomy vs. Expanded Mckissock Surgery for EIC of the Breast
| NCT ID | NCT04052893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shengjing Hospital |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2019-10-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jianyi Li
PRINCIPAL INVESTIGATOR
Shengjing Hospital
Frequently Asked Questions
Who can join the NCT04052893 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 75 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04052893 currently recruiting?
Yes, NCT04052893 is actively recruiting participants. Contact the research team at sjbreast@yeah.net for enrollment information.
Where is the NCT04052893 trial being conducted?
This trial is being conducted at Benxi, China, Shengyang, China, Shenyang, China.
Who is sponsoring the NCT04052893 clinical trial?
NCT04052893 is sponsored by Shengjing Hospital. The principal investigator is Jianyi Li at Shengjing Hospital. The trial plans to enroll 200 participants.