Breast Cancer FemaleRM2prepecNCT04343820
Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)
An observational study of Breast Cancer Female, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2019to 7 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: This study concerns women who have had a mastectomy and want a secondary breast reconstruction by implant.
Who may be able to join
- Woman aged over 18
- Medical history of mastectomy +/- radiotherapy
- Woman requesting breast reconstruction by implant
- Patient treated for non-metastatic cancer
Who cannot join
- Locally uncontrolled disease
- Metastatic disease
- Patient with major cutaneous atrophy allowing only flap reconstruction
- Patients under guardianship or trusteeship
- Patients who objected to the research
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain, 44805
About this study
Official title: Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation : Feasibility, Complications, Evaluation of Aesthetic Result and Quality of Life.
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes.
The objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. It also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session.
Read more
For a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. But the lipo-filling technique allowed to reconsider the management of these patients.
The benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization).
The objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.
Read the detailed description
60 women who have had a mastectomy and want a secondary breast reconstruction by implant at Institut de Cancérologie de l'Ouest well be included in this study.
Patients will be recruited in consultation before the start of reconstruction and up to 18 months after radiation therapy.
They will be followed for 24 months from the end of the breast reconstruction.
The following data will be collected indirectly from the clinical medical record (letters, reports of examinations, consultations, surgical report, hospitalization) of the patient, supplemented if necessary by specific records (radiotherapy records, chemotherapy, physiotherapy management) :
- Clinical data
- Technique-related data
- Complication-related data : adverse events will be evaluated at 15 days, 3 months, 6 months, 12 months and 24 months after reconstruction
- Aesthetic results data : aesthetic result will be evaluated by patients and surgeons at 6 months, 12 months and 24 months after reconstruction
- Quality of life data : a questionnaire will be submitted prior to the intervention, at 12 months and 24 months after reconstruction
Clinicians at Institut de Cancérologie de l'Ouest may be asked to complete the previous informations.
- Conditions
- Breast Cancer Female
- Being tested
- Breast reconstruction
- Keywords
- reconstruction, lipo-modelling, breast cancer, mastectomy, prepectoral implant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reconstructionProcedure or surgery
Breast reconstruction by prepectoral positioned implant after lipo-preparation of the wall.
| Study group | Role | What they receive |
|---|---|---|
| Breast reconstruction | Women who have had a mastectomy and want a secondary breast reconstruction by implant. Receives: Procedure: Breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the complications that occurs after a prepectoral placed implant with lipo-preparation
Pre-surgical implant positioning failure at 12 months. A failure will be defined by the occurence of at least one of the following complications : documented infection ; red breast syndrome ; hematoma ; lymphocele ; delayed healing ; prothesis removal ; stage 1 hull (Baker classification) ; prothesis rotation ; waves / folds ; muscle contractions with prothesis animation ; pain (EVA 4 or 5)
Measured: 12 months
Secondary outcomes (2)
Evaluate the aesthetic result
Aesthetic result will be assessed by giving a mark from 0 to 5 for the following categories : general breast appearance ; breast curve ; breast consistency ; breast volume Both clinician and patient will complete the evaluation.
Measured: 6 months, 12 months and 24 months
Evaluate the quality of life
Patient satisfaction and quality of life will be assessed from Breast Q. The evaluation criteria will be the Breast Q score 24 months after the intervention.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start24 Dec 2019
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoire BRILLAUD-MEFLAH, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343820
- Sponsor's protocol ID
- ICO-N-2018-15
- Acronym
- RM2prepec
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation : Feasibility, Complications, Evaluation of Aesthetic Result and Quality of Life.
- ClinicalTrials.gov ID
- NCT04343820
- Acronym / sponsor ID
- RM2prepec / ICO-N-2018-15
- Conditions
- Breast Cancer Female
- Keywords
- reconstruction, lipo-modelling, breast cancer, mastectomy, prepectoral implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 13 Apr 2020 (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.
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes.
The objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. It also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session.
For a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. But the lipo-filling technique allowed to reconsider the management of these patients.
The benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization).
The objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.
Detailed description
60 women who have had a mastectomy and want a secondary breast reconstruction by implant at Institut de Cancérologie de l'Ouest well be included in this study.
Patients will be recruited in consultation before the start of reconstruction and up to 18 months after radiation therapy.
They will be followed for 24 months from the end of the breast reconstruction.
The following data will be collected indirectly from the clinical medical record (letters, reports of examinations, consultations, surgical report, hospitalization) of the patient, supplemented if necessary by specific records (radiotherapy records, chemotherapy, physiotherapy management) :
- Clinical data
- Technique-related data
- Complication-related data : adverse events will be evaluated at 15 days, 3 months, 6 months, 12 months and 24 months after reconstruction
- Aesthetic results data : aesthetic result will be evaluated by patients and surgeons at 6 months, 12 months and 24 months after reconstruction
- Quality of life data : a questionnaire will be submitted prior to the intervention, at 12 months and 24 months after reconstruction
Clinicians at Institut de Cancérologie de l'Ouest may be asked to complete the previous informations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast reconstruction | – | Procedure: Breast reconstructionWomen who have had a mastectomy and want a secondary breast reconstruction by implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns women who have had a mastectomy and want a secondary breast reconstruction by implant.
Key inclusion criteria (4 listed)
- Woman aged over 18
- Medical history of mastectomy +/- radiotherapy
- Woman requesting breast reconstruction by implant
- Patient treated for non-metastatic cancer
Key exclusion criteria (5 listed)
- Locally uncontrolled disease
- Metastatic disease
- Patient with major cutaneous atrophy allowing only flap reconstruction
- Patients under guardianship or trusteeship
- Patients who objected to the research
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 |
|---|---|---|
| Breast reconstructionBreast reconstruction by prepectoral positioned implant after lipo-preparation of the wall. | Procedure or surgery | Breast reconstruction |
Primary outcome
Describe the complications that occurs after a prepectoral placed implant with lipo-preparation
Time frame: 12 months
Pre-surgical implant positioning failure at 12 months. A failure will be defined by the occurence of at least one of the following complications : documented infection ; red breast syndrome ; hematoma ; lymphocele ; delayed healing ; prothesis removal ; stage 1 hull (Baker classification) ; prothesis rotation ; waves / folds ; muscle contractions with prothesis animation ; pain (EVA 4 or 5)
2 secondary outcomes
Evaluate the aesthetic result
Time frame: 6 months, 12 months and 24 months
Evaluate the quality of life
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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. This study is not recruiting at the moment.
Victoire BRILLAUD-MEFLAH, MD principal investigator
Institut de Cancérologie de l'Ouest
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 Female, run by Institut Cancerologie de l'Ouest 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 17 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the complications that occurs after a prepectoral placed implant with lipo-preparation (time frame: 12 months). 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 17 Feb 2026.