Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT06823414
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Cancer Non-invasive Breast Cancer, run by Alejandra García-Novoa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- What is being tested?
- Video assisted mastectomy
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 1 Apr 2034
- How long will I take part?
- 5 Years
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4
A Coruña, Galicia, 15006
Alejandra García Novoa, Ph.D, 0034981178000 ext. 296158, malejandagarcianovoa@gmail.com
Benigno Acea Nebril, Ph.D., +34981178000 ext. 296158, benigno.acea.nebril@sergas.es
About this study
Official title: Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results
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.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- Being tested
- Video assisted mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video assisted mastectomyOther
Nipple Skin sparing mastectomy assisted by endoscopic or robotic
| Study group | Role | What they receive |
|---|---|---|
| Video assisted mastectomy | Patients with a video-assisted nipple skin sparing mastectomy Receives: Other: Video assisted mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Loss
Safety of the reconstruction technique, calculated by the number of implants lost
Measured: First year after surgery
Secondary outcomes (3)
local relapse
evaluate oncological safety in terms of local relapses
Measured: first 5 years
Glandular residual tissue
Residual glandular tissue after endoscopic mastectomy identified by magnetic resonance imaging one year after the intervention
Measured: first year
Suvival
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Alejandra García-Novoa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alejandra García-Novoa, University Hospital A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823414
- Sponsor's protocol ID
- VideoBreast-24
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results
- ClinicalTrials.gov ID
- NCT06823414
- Acronym / sponsor ID
- VideoBreast-24
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Alejandra García-NovoaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2034 (estimated)
- First posted
- 12 Feb 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video assisted mastectomy | – | Other: Video assisted mastectomyPatients with a video-assisted nipple skin sparing mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- Sarcomas of the breast.
- Benign breast tumors.
- Prepectoral reconstruction with expansion.
- Impossibility to preserve the skin.
- Need for reduction pattern
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 |
|---|---|---|
| Video assisted mastectomyNipple Skin sparing mastectomy assisted by endoscopic or robotic | Other | Video assisted mastectomy |
Primary outcome
Implant Loss
Time frame: First year after surgery
Safety of the reconstruction technique, calculated by the number of implants lost
3 secondary outcomes
local relapse
Time frame: first 5 years
Glandular residual tissue
Time frame: first year
Suvival
Time frame: 5 years
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 12 Feb 2025.
- Background1. 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.
- Individual participant dataSharing planned: Yes
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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.
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 Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Cancer Non-invasive Breast Cancer, run by Alejandra García-Novoa at 1 site in Spain.
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 8 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 12 Feb 2025. 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 Spain. 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 Alejandra García Novoa, PhD MD (981178000 ext. 296113, maria.alejandra.garcia.novoa@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Loss (time frame: First year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823414, which also lists 1 linked publication.
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 12 Feb 2025.