Stage II Breast CancerRESPECTNCT05833659
Comparison Between Prepectoral and Subpectoral Breast Reconstruction
An observational study of Stage II Breast Cancer and Stage I Breast Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stage II Breast Cancer, Stage I Breast Cancer
- What is being tested?
- The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) and having willingness for breast reconstruction.
Who may be able to join
- Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
- Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
- Patients having willingness for breast reconstruction.
- Age between 18 to 70 years.
- Maximum diameter of the cancer lesion ≤ 3 cm.
- Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.
- The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.
Who cannot join
- patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
- Having history of malignant tumor (s) within 5 years.
- Patients under immunosuppressive therapy for organ transplantation.
- Having continuous systemic steroid hormone therapy.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital medical University
Beijing, Beijing Municipality
guoxuan Guo, +861063138712, aliceggx@163.com
About this study
Official title: The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy
There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction.
This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.
Read the detailed description
Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.
- Conditions
- Stage II Breast Cancer, Stage I Breast Cancer
- Being tested
- The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
- Keywords
- breast cancer, endoscopic nipple-sparing mastectomy, breast reconstruction, breast satisfaction, BREAST-Q score
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomyProcedure or surgery
Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| The prepectoral breast reconstruction | The patients received prepectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy Receives: Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy | |
| The subpectoral breast reconstruction | The patients received subpectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy Receives: Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast satisfaction
measured by BREAST-Q score
Measured: 12 months after operation
Secondary outcomes (4)
Physical well-being of chest
measured by BREAST-Q score
Measured: 12 months after operation
Animation deformity
confirmed by the doctor's physical examination
Measured: 12 months after operation
Adverse events
according to Clavien-Dindo system
Measured: within 30 days after surgery
Local recurrence and distant metastasis of breast cancer
physical examination or imaging examination with histologically confirmed
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Mar 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Health Promotion Association
- Responsible party
- Sponsor
- Investigators
- guoxuan gao, MD, Principal investigator, Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833659
- Sponsor's protocol ID
- RESPECT
- Acronym
- RESPECT
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy
- ClinicalTrials.gov ID
- NCT05833659
- Acronym / sponsor ID
- RESPECT / RESPECT
- Conditions
- Stage II Breast Cancer, Stage I Breast Cancer
- Keywords
- breast cancer, endoscopic nipple-sparing mastectomy, breast reconstruction, breast satisfaction, BREAST-Q score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Health Promotion Association
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Apr 2023 (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.
There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction.
This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.
Detailed description
Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The prepectoral breast reconstruction | – | Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomyThe patients received prepectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy |
| The subpectoral breast reconstruction | – | Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomyThe patients received subpectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) and having willingness for breast reconstruction.
Key inclusion criteria (8 listed)
- Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
- Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
- Patients having willingness for breast reconstruction.
- Age between 18 to 70 years.
- Maximum diameter of the cancer lesion ≤ 3 cm.
Key exclusion criteria (5 listed)
- patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
- Having history of malignant tumor (s) within 5 years.
- Patients under immunosuppressive therapy for organ transplantation.
- Having continuous systemic steroid hormone therapy.
- Pregnant or lactating women.
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 |
|---|---|---|
| The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomyGroup A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction | Procedure or surgery | The prepectoral breast reconstruction, The subpectoral breast reconstruction |
Primary outcome
breast satisfaction
Time frame: 12 months after operation
measured by BREAST-Q score
4 secondary outcomes
Physical well-being of chest
Time frame: 12 months after operation
Animation deformity
Time frame: 12 months after operation
Adverse events
Time frame: within 30 days after surgery
Local recurrence and distant metastasis of breast cancer
Time frame: 12 months after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
guoxuan gao, MD principal investigator
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage II Breast Cancer and Stage I Breast Cancer, run by Beijing Friendship Hospital at 1 site 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact guoxuan gao, MD (+861063138712, aliceggx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast satisfaction (time frame: 12 months after operation). 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 27 Apr 2023; AzTrials last refreshed its copy on 1 Nov 2026.