Breast NeoplasmsNCT04052893
DFS and QOL After Modified Radical Mastectomy vs. Expanded Mckissock Surgery for EIC of the Breast
A study testing Expanded Mckissock surgery and Modified radical mastectomy in people with Breast Neoplasms, run by Shengjing Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Expanded Mckissock surgery and Modified radical mastectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- 1 Oct 2019to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group
Benxi, Liaoning, 117000
Qiang Sun, MS, 13390358188, sq1338@hotmail.com
Qiang Sun, MS
- Recruiting
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Shengyang, Liaoning, 110042
Jianyi Li, Dr., 13390127607, sjbreast@yeah.net
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Jianyi Li, +8618940257177, sjbreast@yeah.net
About this study
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
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Expanded Mckissock surgery, Modified radical mastectomy
- Keywords
- Surgery, Plastic
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Mckissock surgeryProcedure or 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 areola preserved. (4) The cutting-edge of nipple-areola complex will be sent for cancer screening. The axillary lymph node biopsy or cleaning will be performed along the outer edge of the pectoralis major muscle. (5) 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.
Modified radical mastectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 100 patients will be assigned into a study group. Receives: Procedure: Expanded Mckissock surgery |
| Control group | Active comparator | 100 patients will be assigned into a control group. Receives: Procedure: Modified radical mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 5 years
Medical cost
Including medical insurance and commercial insurance reimbursement.
Measured: During hospitalization, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Oct 2019
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyi Li, Shengjing Hospital
- Investigators
- Jianyi Li, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052893
- Sponsor's protocol ID
- Shengjing-LJY02
- Status last verified
- Feb 2022
- First submitted
- 6 Aug 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04052893
- Acronym / sponsor ID
- Shengjing-LJY02
- Conditions
- Breast Neoplasms
- Keywords
- Surgery, Plastic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Expanded Mckissock surgery100 patients will be assigned into a study group. |
| Control group | Active comparator | Procedure: Modified radical mastectomy100 patients will be assigned into a control group. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded Mckissock surgeryExpanded 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 areola preserved. (4) The cutting-edge of nipple-areola complex will be sent for cancer screening. The axillary lymph node biopsy or cleaning will be performed along the outer edge of the pectoralis major muscle. (5) 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. | Procedure or surgery | Study group |
| Modified radical mastectomyThe 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. | Procedure or surgery | Control group |
Primary outcome
Disease-free survival.
Time frame: 5 years
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianyi Li principal investigator
Shengjing Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Mckissock surgery and Modified radical mastectomy in people with Breast Neoplasms, run by Shengjing Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianyi Li (+8618940257177, sjbreast@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.