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Clinical Trial NCT04052893 for Breast Neoplasms is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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DFS and QOL After Modified Radical Mastectomy vs. Expanded Mckissock Surgery for EIC of the Breast 200

Recruiting
Clinical Trial NCT04052893 is an interventional study for Breast Neoplasms that is recruiting. It started on 1 October 2019 with plans to enroll 200 participants. Led by Shengjing Hospital, it is expected to complete by 1 September 2026. The latest data from ClinicalTrials.gov was last updated on 8 February 2022.
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. Mckissoc...Show More
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 extens...Show More
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

Conditions
Breast Neoplasms
Other Study IDs
  • Shengjing-LJY02
NCT ID Number
NCT04052893
Start Date (Actual)
2019-10-01
Last Update Posted
2022-02-08
Completion Date (Estimated)
2026-09-01
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Surgery
Plastic
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalStudy group
100 patients will be assigned into a study group.
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...Show More
Active ComparatorControl group
100 patients will be assigned into a control group.
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
Outcome MeasureMeasure DescriptionTime Frame
Disease-free survival.
Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.
5 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23) scale
The QLQ-BR23 scale will evaluate the quality of life. The QLQ-BR23 scale consists of 23 items with a full score of 92. Higher score indicates poor quality of life.
5 years
Breast symmetry
The symmetry of reconstructed breast will be evaluated using Harris score. The Harris score was described by Harris et al. (Int J Radiat Oncol Biol Phys 1979; 5: 257- 261.) It will be divided into four levels: excellent, good, fair, and poor.
5 years
Medical cost
Including medical insurance and commercial insurance reimbursement.
During hospitalization, an average of 2 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
45 Years
Eligible Sexes
Female
  • 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.

  • 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.
Shengjing Hospital logoShengjing Hospital
Study Responsible Party
Jianyi Li, Principal Investigator, Principal Investigator, Shengjing Hospital
Study Central Contact
Contact: Jianyi Li, +8618940257177, [email protected]
3 Study Locations in 1 Countries

Liaoning

General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group, Benxi, Liaoning, 117000, China
Qiang Sun, MS, Contact, 13390358188, [email protected]
Qiang Sun, MS, Principal Investigator
Recruiting
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shengyang, Liaoning, 110042, China
Jianyi Li, Dr., Contact, 13390127607, [email protected]
Recruiting
Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China
Jianyi Li, Contact, +8618940257177, [email protected]
Recruiting