Breast CancerPhase 2MARCINCT02673268
Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
A Phase 2 study testing Mastectomy and Da Vinci Robot Xi in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis. The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mastectomy and Da Vinci Robot Xi
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2015to Nov 2020
- Phase
- Phase 2
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 .Patients with an indication of mastectomy with areola conservation 2. In case of carcinologic surgery:
- Disease located more than 2cm of the areola on the clinical and paraclinical evaluation
- Patients with indication of total mastectomy
- Patients looking for immediate reconstruction 3. In case of prophylactic surgery
- Patients wishing a prophylactic surgery because of highly risked mutation (BRCA1, BRCA2....) 4. Cup A, B or C maximum 5. Aged between 18 and 70 years old 6. OMS 0, 1 7. Signed informed consent 8. Patients affiliated to a social security system
Who cannot join
- Patients with a high risk of skin necrosis
- Planned post operative radiotherapy
- Patients with an historic of breast surgery on the side that needs to be operated
- Pregnant or breastfeeding women
- Persons deprived of liberty
- Persons not able to undergo medical follow up due to geographical, social or psychic reasons
Trial locations and contacts
1 site in 1 country.
Stefan Michels, PhD contact
France1 site, 1 recruiting
- Recruiting
Gustave Roussy Cancer Campus
Villejuif, Val de Marne, 94805
Benjamin Sarfati, MD, Benjamin.sarfati@gustaveroussy.fr
Stefan Michiels, PhD, Stefan.michiels@gustaveroussy.fr
About this study
The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis.
The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm.
The aim is also to study the rate of complications, cosmetic results and quality of life.
- Conditions
- Breast Cancer
- Being tested
- Mastectomy, Da Vinci Robot Xi
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastectomyProcedure or surgery
Da Vinci Robot XiDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer | Experimental | Not described Receives: Procedure: Mastectomy; Device: Da Vinci Robot Xi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of necrosis
Measured: Assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start25 Nov 2015
- Primary completionNov 2019 (estimated)
- Study completionNov 2020 (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 CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673268
- Sponsor's protocol ID
- 2015-A00745-44
- Other IDs
- 2015/2250
- Acronym
- MARCI
- Status last verified
- Oct 2017
- First submitted
- 1 Feb 2016
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
PubMed 29959612
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
- ClinicalTrials.gov ID
- NCT02673268
- Acronym / sponsor ID
- MARCI / 2015-A00745-44
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- 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.
The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis.
The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm.
The aim is also to study the rate of complications, cosmetic results and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer | Experimental | Procedure: Mastectomy, Device: Da Vinci Robot Xi |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1 .Patients with an indication of mastectomy with areola conservation 2. In case of carcinologic surgery:
- Disease located more than 2cm of the areola on the clinical and paraclinical evaluation
- Patients with indication of total mastectomy
- Patients looking for immediate reconstruction 3. In case of prophylactic surgery
- Patients wishing a prophylactic surgery because of highly risked mutation (BRCA1, BRCA2....) 4. Cup A, B or C maximum 5. Aged between 18 and 70 years old 6. OMS 0, 1 7. Signed informed consent 8. Patients affiliated to a social security system
Key exclusion criteria (6 listed)
- Patients with a high risk of skin necrosis
- Planned post operative radiotherapy
- Patients with an historic of breast surgery on the side that needs to be operated
- Pregnant or breastfeeding women
- Persons deprived of liberty
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 |
|---|---|---|
| Mastectomy | Procedure or surgery | Patients with breast cancer |
| Da Vinci Robot Xi | Device | Patients with breast cancer |
Primary outcome
Rate of necrosis
Time frame: Assessed up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Derived from this study: PubMed 29959612Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
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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.
Stefan Michels, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mastectomy and Da Vinci Robot Xi in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Oct 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Sarfati, MD (0142114384 ext. +33, Benjamin.sarfati@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of necrosis (time frame: Assessed up to 1 year). 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 NCT02673268, 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 Oct 2017.