Breast CancerNCT07069803
Oncologic Outcomes of Minimal Access Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer
An observational study of Breast Cancer, run by Changhua Christian Hospital.
Trial summary
In this study the investigators investigate the oncological outcomes of minimal access nipple sparing mastectomy compared with conventional nipple sparing mastectomy for the treatment of breast cancer Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,129 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2000to 30 Mar 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: NSM patients at CCH
Who may be able to join
- primary operable breast cancer and had undergone NSM
Who cannot join
- had metastatic disease, non-malignant breast disease cases, bilateral breast cancer cases, recurrent breast cancer as well as male breast cancer cases and patients who did not undergo NSM
About this study
Official title: Long-term Oncologic Outcomes of Minimal Access (Endoscopic or Robotic Assisted) Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer - a Propensity Score Matching Analysis
In this study the investigators investigate the oncological outcomes of minimal access nipple sparing mastectomy compared with conventional nipple sparing mastectomy for the treatment of breast cancer
Read the detailed description
A retrospective analysis of a prospectively collected database was conducted from single institute to compare the oncologic outcomes of MA-NSM versus C-NSM. The clinical results and oncologic outcome (margin involved rate, local recurrence and overall survival) were compared between groups. To prevent bias, a case control approach was conducted with propensity score matching (PSM) method.
- Conditions
- Breast Cancer
- Keywords
- nipple-sparing mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| minimal acccess NSM | minimal acccess NSM | |
| conventional NSM | conventional NSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence
local recurrence
Measured: 10 years
distant metastasis
distant metastasis
Measured: 10 years
disease free survival
disease free survival
Measured: 10 years
overall survival
overall survival
Measured: 10 years
Secondary outcomes (3)
operative duration
operative duration
Measured: during surgery
intra-operative blood loss
intra-operative blood loss
Measured: during surgery
post-operative complications
post-operative complications
Measured: 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Feb 2000
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 1,129 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Su, MBBS, FRCS, Study director, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069803
- Sponsor's protocol ID
- CCH-IRB-231217
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Oncologic Outcomes of Minimal Access (Endoscopic or Robotic Assisted) Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer - a Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT07069803
- Acronym / sponsor ID
- CCH-IRB-231217
- Conditions
- Breast Cancer
- Keywords
- nipple-sparing mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,129 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Feb 2000 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 17 Jul 2025 (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.
In this study the investigators investigate the oncological outcomes of minimal access nipple sparing mastectomy compared with conventional nipple sparing mastectomy for the treatment of breast cancer
Detailed description
A retrospective analysis of a prospectively collected database was conducted from single institute to compare the oncologic outcomes of MA-NSM versus C-NSM. The clinical results and oncologic outcome (margin involved rate, local recurrence and overall survival) were compared between groups. To prevent bias, a case control approach was conducted with propensity score matching (PSM) method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimal acccess NSM | – | –minimal acccess NSM |
| conventional NSM | – | –conventional NSM |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NSM patients at CCH
Key inclusion criteria (1 listed)
- primary operable breast cancer and had undergone NSM
Key exclusion criteria (1 listed)
- had metastatic disease, non-malignant breast disease cases, bilateral breast cancer cases, recurrent breast cancer as well as male breast cancer cases and patients who did not undergo NSM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
local recurrence
Time frame: 10 years
local recurrence
distant metastasis
Time frame: 10 years
distant metastasis
disease free survival
Time frame: 10 years
disease free survival
overall survival
Time frame: 10 years
overall survival
3 secondary outcomes
operative duration
Time frame: during surgery
intra-operative blood loss
Time frame: during surgery
post-operative complications
Time frame: 30 days post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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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.
Jun Su, MBBS, FRCS study director
Changhua Christian Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Changhua Christian Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence (time frame: 10 years). The study lists 4 primary outcomes in all. 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 17 Jul 2025.