NCT07069803

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,129

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
24.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

24.2 years

First QC Date

June 26, 2025

Last Update Submit

July 7, 2025

Conditions

Breast Cancer

Keywords

nipple-sparing mastectomy

Outcome Measures

Primary Outcomes (4)

  • local recurrence

    local recurrence

    10 years

  • distant metastasis

    distant metastasis

    10 years

  • disease free survival

    disease free survival

    10 years

  • overall survival

    overall survival

    10 years

Secondary Outcomes (3)

  • operative duration

    during surgery

  • intra-operative blood loss

    during surgery

  • post-operative complications

    30 days post-operatively

Study Arms (2)

minimal acccess NSM

minimal acccess NSM

conventional NSM

conventional NSM

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

NSM patients at CCH

You may qualify if:

  • primary operable breast cancer and had undergone NSM

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jun Su, MBBS, FRCS

    Changhua Christian Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 17, 2025

Study Start

February 1, 2000

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

July 17, 2025

Record last verified: 2025-07