Breast CarcinomaPhase 2M-RICNCT01199354
Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)
A Phase 2 study testing Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap. in people with Breast Carcinoma, run by Clinique Clementville at 11 sites in France.
Trial summary
The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 11 sitesFrance
- Study dates
- Jul 2010to Jul 2017
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women < 75 year old
- Invasive breast carcinoma, indication for mastectomy
- Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier...
Who cannot join
- Women older than 75
- Metastatic breast carcinoma
- Antecedents of previously treated homolateral breast carcinoma
- Documented cancer progression
- Smoker at the moment of the indication surgery
- Known diabetes, neoadjuvant hormonal treatment...
Trial locations and contacts
11 sites in 1 country.
Magali Lacroix contact
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
Polyclinique Urbain V
Avignon
Bernard Miramand, miramand@wanadoo.fr
- Not yet recruiting
Polyclinique Urbain V
Avignon
Nicolas Sterkers, nica_sterckers@yahoo.fr
- Not yet recruiting
Centre Jean Perrin
Clermont-Ferrand
Jacques Dauplat
- Not yet recruiting
Groupe Hospitalier Mutualiste Clinique les Eaux Claires
Grenoble
Philippe Gabelle
- Not yet recruiting
Centre Léon Bérard
Lyon
Catherine Bouteille, bouteill@lyon.fnclcc.fr
- Not yet recruiting
Institut Paoli Calmettes
Marseille
Gilles Houvenaeghel, houvenag@marseille.free.fr
- Not yet recruiting
Institut Paoli Calmettes
Marseille
Monique Cohen, chirurgie2@marseille.free.fr
- Recruiting
Clinique Clementville
Montpellier
Pierre Berrand, pa.bertrand@wanadoo.fr
- Not yet recruiting
CRLCC Val d'Aurelle
Montpellier
Marian Gutowski, gutowski@valdorel.fnclcc.fr
- Not yet recruiting
Clinique Belledonne
Saint-Martin-d'Hères
Raoul Payan, desm.paya@wanadoo.fr
- Not yet recruiting
Institut Claudius Regaud
Toulouse
Hélène Charitansky, helene.charitansky@orange.fr
About this study
Official title: Phase II Study: Assessing the Feasibility and Morbidity of Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.
The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.
- Conditions
- Breast Carcinoma
- Being tested
- Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.
- Keywords
- Invasive breast carcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.Procedure or surgery
Mastectomy, preservation of the skin envelope, removal of the nipple-areolar complex and dissection of the axillary lymph nodes followed by immediate reconstruction with autologous latissimus dorsi flap with or without prosthesis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of skin necrosis
To evaluate the incidence of skin necrosis in case of treatment with skin sparing mastectomy and immediate breas reconstruction with latissimus dorsi myocutaneous flap after neoadjuvant chemotherapy and radiotherapy.
Secondary outcomes (1)
Rate of histological remission of the surgical specimen based on the anatomopathological examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJul 2010
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies 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
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Clementville
- Sponsor type
- University, hospital or other
- Investigators
- Cécile Zinzindhoue, Principal investigator, Clinique Clementville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199354
- Sponsor's protocol ID
- CLEM-01
- Acronym
- M-RIC
- Status last verified
- Jun 2011
- First submitted
- 8 Sep 2010
- Last updated
- 9 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Assessing the Feasibility and Morbidity of Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.
- ClinicalTrials.gov ID
- NCT01199354
- Acronym / sponsor ID
- M-RIC / CLEM-01
- Conditions
- Breast Carcinoma
- Keywords
- Invasive breast carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Clinique ClementvilleUniversity, hospital or other
- Study start
- Jul 2010
- Study completion
- Jul 2017 (estimated)
- First posted
- 10 Sep 2010 (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 aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women < 75 year old
- Invasive breast carcinoma, indication for mastectomy
- Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier...
Key exclusion criteria (6 listed)
- Women older than 75
- Metastatic breast carcinoma
- Antecedents of previously treated homolateral breast carcinoma
- Documented cancer progression
- Smoker at the moment of the indication surgery
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, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.Mastectomy, preservation of the skin envelope, removal of the nipple-areolar complex and dissection of the axillary lymph nodes followed by immediate reconstruction with autologous latissimus dorsi flap with or without prosthesis. | Procedure or surgery | – |
Primary outcome
Incidence of skin necrosis
To evaluate the incidence of skin necrosis in case of treatment with skin sparing mastectomy and immediate breas reconstruction with latissimus dorsi myocutaneous flap after neoadjuvant chemotherapy and radiotherapy.
1 secondary outcome
Rate of histological remission of the surgical specimen based on the anatomopathological examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Magali Lacroix contact
Cécile Zinzindhoue principal investigator
Clinique Clementville
11 sites 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, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap. in people with Breast Carcinoma, run by Clinique Clementville at 11 sites 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 3 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 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 Magali Lacroix (m.lacroix@millenaire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of skin necrosis. 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 9 Jun 2011.