NCT06823414

Brief Summary

Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
97mo left

Started Feb 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress14%
Feb 2025Apr 2034

Study Start

First participant enrolled

February 1, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

4.2 years

First QC Date

February 2, 2025

Last Update Submit

February 6, 2025

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Cancer Non-invasive Breast CancerHigh Risk Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Implant Loss

    Safety of the reconstruction technique, calculated by the number of implants lost

    First year after surgery

Secondary Outcomes (3)

  • local relapse

    first 5 years

  • Glandular residual tissue

    first year

  • Suvival

    5 years

Study Arms (1)

Video assisted mastectomy

Patients with a video-assisted nipple skin sparing mastectomy

Other: Video assisted mastectomy

Interventions

Video assisted mastectomyOTHER

Nipple Skin sparing mastectomy assisted by endoscopic or robotic

Video assisted mastectomy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with breast cancer or high risk for breast cancer who need a mastectomy. The mastectomy will be skin and nipple preserving and will be performed with endoscopic assistance

You may qualify if:

  • Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.

You may not qualify if:

  • Sarcomas of the breast.
  • Benign breast tumors.
  • Prepectoral reconstruction with expansion.
  • Impossibility to preserve the skin.
  • Need for reduction pattern
  • Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.).
  • Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations.
  • Refusal of the patient to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4

A Coruña, Galicia, 15006, Spain

RECRUITING

Related Publications (1)

  • 1. Acea-Nebril B, García-Novoa A, Cereijo-Garea C, Conde C, Bouzón A, Díaz C. Safety and Quality of Life in Women with Immediate Reconstruction with Polyurethane Implants after Neoadjuvant Chemotherapy: Outcomes from The Preq-20 Trial. Cancers 2023;15(4):1113. doi: 10.3390/cancers15041113. 2. Acea B, García A, García L, Díaz C, Bouzón A, Conde C. Immediate breast reconstruction by prepectoral polyurethane implant: Preliminary results of the prospective study PreQ-20. Cir Esp (Engl Ed) 2023;101(3):187-197. doi: 10.1016/j.cireng.2022.09.021. 3. Nakajima H, Sakaguchi K, Mizuta N, et al. Video-assisted total glandectomy and immediate reconstruction for breast cancer. Biomed Pharmacother 2002;56 Suppl 1:205s-8s. 4. Wei Ch, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast; 2019:46:144-156. doi: 10.1016/j.breast.2019.05.013. 5. Wei Ch, Lai HW. Evolution of minimal access breast surgery. Gland Surg 2019;8(6):784-793. doi: 10.21037/gs.2019.11.16. 6. Toesca A, Paradze N, Manconi A, Galimberti V, Intra M, Colleoni M et al. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast 2017; Feb:31:51-56. doi: 10.1016/j.breast.2016.10.009. 7. Rathat G, Herlin C, Bonnel C, Captier G, Duraes M. Endoscopic Nipple-Sparing Mastectomy with Immediate Prepectoral Implant-Based Reconstruction: A Case Report Am J Case Rep 2019;20:1812-1816. doi: 10.12659/AJCR.919669.

    BACKGROUND

Central Study Contacts

Alejandra García Novoa, PhD MD

CONTACT

981178000maria.alejandra.garcia.novoa@sergas.es

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2025

First Posted

February 12, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2034

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Locations

ES(1)