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Completed

NCT Number: NCT07069803

Oncologic Outcomes of Minimal Access Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary operable breast cancer and had undergone NSM

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. local recurrence

    Time frame: 10 years

    local recurrence

  2. distant metastasis

    Time frame: 10 years

    distant metastasis

  3. disease free survival

    Time frame: 10 years

    disease free survival

  4. overall survival

    Time frame: 10 years

    overall survival

Secondary outcomes

  1. operative duration

    Time frame: during surgery

    operative duration

  2. intra-operative blood loss

    Time frame: during surgery

    intra-operative blood loss

  3. post-operative complications

    Time frame: 30 days post-operatively

    post-operative complications

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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