Breast CancerNEOMAMENDONCT06569706
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
A study testing Nipple-Sparing Mastectomy, with immediate breast reconstruction in people with Breast Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Nipple -Sparing Mastectomy (NSM), with immediate breast reconstruction (IBR) can be offered to patients requiring mastectomy when the lesion is more than 2cm from the nipple. Endoscopic mastectomy is a technical alternative for small-volume breasts (cup sizes A, B, C), offering a NSM with IBR, but also concealing the… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nipple-Sparing Mastectomy, with immediate breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2024to 18 Oct 2029
- Phase
- Interventional
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 20 and 75 years.
- Patient with an indication for curative mastectomy, either unilateral or bilateral, with nipple preservation:
- Extensive Carcinoma In Situ (CIS), more than 2 cm from the nipple
- Multicentric Infiltrating Carcinoma (IC), more than 2 cm from the nipple
- Large volume Infiltrating Carcinoma, more than 2 cm from the nipple
- IC or CIS for which the patient refuses conservative treatment, more than 2 cm from the nipple
Show all 9Show fewer
- Breast volumes: cup sizes A, B, or C as defined by underwear size, and glandular ptosis not exceeding grade 2 according to Regnault's classification
- Patient wishing to undergo immediate breast reconstruction.
- WHO/OMS (World Health Organization/Organisation Mondiale de la Santé) performance status <3
Who cannot join
- Cutaneous carcinoma
- Inflammatory breast
- History of oncological breast surgery on the same breast
- Patient who has received radiation treatment on the same breast
- Breast hypertrophy requiring a nipple-bearing flap
- Smoking ≥ 10 cigarettes/day
Show all 15Show fewer
- BMI > 35
- Protected patient or unable to give consent according to Article L1121-8 of the French Public Health Code (CSP).
- Patient participating in another interventional clinical study.
- ASA (physical status score of the American Society of Anesthesiologists) >2.
- Pregnant or breastfeeding women according to Article L1121-5 of the CSP.
- Vulnerable persons (those receiving psychiatric care, those deprived of liberty, and those admitted to a health or social institution) according to Article L1121-6 of the CSP.
- Absence of effective contraception for patients of childbearing age.
- Absence of affiliation with a social security scheme.
- Absence of collected free, informed, and written consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
RATHAT GAUTHIER, MD, 467336421 ext. 33, g-rathat@chu-montpellier.fr
DURAES Martha, MD, 631329158 ext. 33, duraesmartha@gmail.com
About this study
Nipple -Sparing Mastectomy (NSM), with immediate breast reconstruction (IBR) can be offered to patients requiring mastectomy when the lesion is more than 2cm from the nipple. Endoscopic mastectomy is a technical alternative for small-volume breasts (cup sizes A, B, C), offering a NSM with IBR, but also concealing the scar on the axillary line. It can be performed with traditional laparoscopic equipment, making this technique much more accessible and less costly than robotic mastectomy. It uses a single-port device that is significantly less costly than robotic equipment.
Feasibility and safety studies remain limited to the Asian continent, and it would undoubtedly be beneficial to initiate research in Europe to add this new technical option to our surgical arsenal. This study project aims to explore the feasibility and safety of endoscopic nipple-sparing mastectomy for breast cancer indications in a French center.
Read the detailed description
It s a practicability study, evaluating endoscopic approach for mastectomy, using an axillary single port in breast cancer patients. Conventional surgery conversion rate, operative time, infectious rate, esthetical outcomes, oncological safety and functional outcomes will be evaluated.
- Conditions
- Breast Cancer
- Being tested
- Nipple-Sparing Mastectomy, with immediate breast reconstruction
- Keywords
- Subcutaneous Mastectomy, Endoscopy, Breast reconstruction, Breast implants, Cancer patients
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipple-Sparing Mastectomy, with immediate breast reconstructionProcedure or surgery
Also called Endoscopic approach of nipple-sparing mastectomy, with immediate breast reconstruction
It is an endoscopic approach for mastectomy using an axillary single port
| Study group | Role | What they receive |
|---|---|---|
| Nipple-Sparing Mastectomy, with immediate breast reconstruction | Experimental | 20 patients female with breast cancer will have a Nipple-Sparing Mastectomy, with immediate breast reconstruction Receives: Procedure: Nipple-Sparing Mastectomy, with immediate breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients.
The E-NSM is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position.
- Complete excision of the gland by means of an incision on the axillary line, installation of a definitive smooth prosthesis, absence of conversion to a conventional approach.
Measured: one day
Secondary outcomes (13)
Operative time
Duration of the prophylactic mastectomy with immediate breast reconstruction
Measured: one day
Hospital stay
The duration of hospitalization will be noted upon discharge from hospitalization
Measured: Through discharge from hospitalization, an average of 7 days
Open surgery conversion rate
Number of patients with open surgery conversion
Measured: one day
Oncologic safety of this approach
Evaluation of the early local recurrence of breast cancer rate at 1 and 2 year by imaging (breast ultrasound and/or MRI) and clinical examination.
Recurrence will be defined by an attenuating tissue mass on ultrasound and/or suspicious contrast on MRI and/or a clinically palpable nodule, that will be confirmed by biopsy with histological analysis.
Measured: 1 and 2 years after surgery
Concealed nature of the breast scar
Number of patients with no visible scars, picture taken bare chest front and side after the surgery
Measured: Before surgery and 1 month and 3 months after surgery
Number of participants with an infection
Number of participants with postoperative infection after the mastectomy, including cases requiring implant replacement or removal.
Measured: At surgery, and 1, 3, months after surgery
Skin case necrosis
The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if > 25%
Measured: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Complication rates (ischemia)
Nipple-Areola-Complex (NAC) Ischemia: comparison with literature data on conventional surgery, including grading of ischemia
Measured: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Number of participants with a local haematoma
Number of participants with a local haematoma caused by the mastectomy with immediate breast reconstruction requiring surgical intervention.
Measured: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Post-operative seromas
Number of patients with seromas after the mastectomy
Measured: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Necrosis of areolo-nipple plaque
The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.
Measured: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Aesthetic result
BREAST-Q© questionnaire Version 1.0 measure the quality of life and satisfaction among patients undergoing breast surgery. This questionnaire includes 6 modules: 1) Augmentation module, 2) Reduction/Mastectomy module, 3) Breast cancer: a) Mastectomy module, b) Reconstruction module, c) Breast reconstruction expectations module, d) Breast conserving therapy module.
The conceptual framework of the modules is comprised of following two overarching themes (or domains): 1) Health-related quality of life and 2) Patient satisfaction. 1) Under each of these domains, there are six subthemes; Quality of life: 1) Psychosocial, 2) Physical and 3) Sexual well-being; and Patient satisfaction: 4) Satisfaction with Breasts, 5) Satisfaction with Outcome and 6) Satisfaction with care.
Cf. https://qportfolio.org/wp-content/uploads/2023/01/BREAST-Q-BREAST-CANCER-USER-GUIDE.pdf for the response options.
Measured: 90 days and 1 year after surgery
Life quality
Quality of life with an european quality of life scale (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, few problems, some problems, severe problems and extreme problems. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having few problems for 2, some problems for 3, severe problems for 4, and having extreme problems for 5. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions).
Measured: Before surgery and 90 days and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start18 Oct 2024
- Primary completion18 Oct 2026 (estimated)
- Study completion18 Oct 2029 (estimated)
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569706
- Sponsor's protocol ID
- 24_0132_UF7830
- Other IDs
- 2024-A01008-39
- Acronym
- NEOMAMENDO
- Status last verified
- Dec 2025
- First submitted
- 13 Aug 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06569706
- Acronym / sponsor ID
- NEOMAMENDO / 24_0132_UF7830
- Conditions
- Breast Cancer
- Keywords
- Subcutaneous Mastectomy, Endoscopy, Breast reconstruction, Breast implants, Cancer patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 18 Oct 2026 (estimated)
- Study completion
- 18 Oct 2029 (estimated)
- First posted
- 26 Aug 2024 (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.
Nipple -Sparing Mastectomy (NSM), with immediate breast reconstruction (IBR) can be offered to patients requiring mastectomy when the lesion is more than 2cm from the nipple. Endoscopic mastectomy is a technical alternative for small-volume breasts (cup sizes A, B, C), offering a NSM with IBR, but also concealing the scar on the axillary line. It can be performed with traditional laparoscopic equipment, making this technique much more accessible and less costly than robotic mastectomy. It uses a single-port device that is significantly less costly than robotic equipment.
Feasibility and safety studies remain limited to the Asian continent, and it would undoubtedly be beneficial to initiate research in Europe to add this new technical option to our surgical arsenal. This study project aims to explore the feasibility and safety of endoscopic nipple-sparing mastectomy for breast cancer indications in a French center.
Detailed description
It s a practicability study, evaluating endoscopic approach for mastectomy, using an axillary single port in breast cancer patients. Conventional surgery conversion rate, operative time, infectious rate, esthetical outcomes, oncological safety and functional outcomes will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nipple-Sparing Mastectomy, with immediate breast reconstruction | Experimental | Procedure: Nipple-Sparing Mastectomy, with immediate breast reconstruction20 patients female with breast cancer will have a Nipple-Sparing Mastectomy, with immediate breast reconstruction |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women between 20 and 75 years.
- Patient with an indication for curative mastectomy, either unilateral or bilateral, with nipple preservation:
- Breast volumes: cup sizes A, B, or C as defined by underwear size, and glandular ptosis not exceeding grade 2 according to Regnault's classification
- Patient wishing to undergo immediate breast reconstruction.
- WHO/OMS (World Health Organization/Organisation Mondiale de la Santé) performance status <3
Key exclusion criteria (15 listed)
- Cutaneous carcinoma
- Inflammatory breast
- History of oncological breast surgery on the same breast
- Patient who has received radiation treatment on the same breast
- Breast hypertrophy requiring a nipple-bearing flap
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 |
|---|---|---|
| Nipple-Sparing Mastectomy, with immediate breast reconstructionAlso: Endoscopic approach of nipple-sparing mastectomy, with immediate breast reconstructionIt is an endoscopic approach for mastectomy using an axillary single port | Procedure or surgery | Nipple-Sparing Mastectomy, with immediate breast reconstruction |
Primary outcome
Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients.
Time frame: one day
The E-NSM is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position. - Complete excision of the gland by means of an incision on the axillary line, installation of a definitive smooth prosthesis, absence of conversion to a conventional approach.
13 secondary outcomes
Operative time
Time frame: one day
Hospital stay
Time frame: Through discharge from hospitalization, an average of 7 days
Open surgery conversion rate
Time frame: one day
Oncologic safety of this approach
Time frame: 1 and 2 years after surgery
Concealed nature of the breast scar
Time frame: Before surgery and 1 month and 3 months after surgery
Number of participants with an infection
Time frame: At surgery, and 1, 3, months after surgery
Skin case necrosis
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Complication rates (ischemia)
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Number of participants with a local haematoma
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Post-operative seromas
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Necrosis of areolo-nipple plaque
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Aesthetic result
Time frame: 90 days and 1 year after surgery
Life quality
Time frame: Before surgery and 90 days and 1 year after surgery
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 5 Jan 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Nipple-Sparing Mastectomy, with immediate breast reconstruction in people with Breast Cancer, run by University Hospital, Montpellier at 1 site in France.
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 9 inclusion and 15 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 5 Jan 2026. 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 France. 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 Gauthier Rathat, MD (467336532 ext. +33, g-rathat@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients. (time frame: one day). 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 5 Jan 2026.