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At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of reconstruction adopted. This is true all the more as it is about a reconstruction by prosthesis because of the prothetic died risk of hull(shell).
Teams proposed immediate mammary reconstructions to expanding (carrier) patients of carcinoma infiltrating, sometimes locally moved forward. For these patients, was not brought back(reported) by increase of the risk of local or remote relapse.
Two studies estimated afterward the feasibility of the mastectomy with immediate mammary reconstruction at the close of the chemotherapy and of the radiotherapy. The rate of morbidity is judged as acceptable. The rate of local second offense(recurrence) was similar to the patients benefiting from the classic therapeutic plan.
During an other study ( M-RIC), it was shown that the inversion of therapeutic sequence is possible and that by prescribing the chemotherapy and the radiotherapy before immediate mammary reconstruction, the morbidity is acceptable.
It is acquired that the chemotherapy néoadjuvant is equivalent to the post-operative chemotherapy as regards the global survival.
On the other hand, the rate of histological answer, according to subgroups, is very different. This rate can vary of 9 % for tumors RH +, negative Her2 in 45 % for tumors RH-, Her2 over expression. There are 33 % for the RH +, Her2 + and of 35 % for triple-negative.
The purpose of the investigators study is to estimate the rate of histological response during the inversion of therapeutic sequence to make sure of the oncologic safety(security), in particular by molecular subgroups, considering the heterogeneousness of the results(profits) after chemotherapy néoadjuvant only. Sataloff and Chevallier Classifications is the references and will be used here, but the investigators can also use Symmans classification in addition.
The rate of local and metastatic second offenses(recurrences) will also be estimated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Mammary Reconstruction | Experimental | Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate mammary reconstruction | Procedure | Chemotherapy administration then radiotherapy and then surgery : mastectomy and immediate mammary reconstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of histological response of an infiltrating tumor within various molecular subgroups | Tumor Histological response (group RH+ Her2+, group RH+ Her2-, group RH- Her2+, and group RH- Her2-) | from surgery up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ganglionar response on the axillary lymph nodes after chemotherapy and radiotherapy néoadjuvant | Number of lymph nodes collected and number of positive lymph nodes | from surgery up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of local and metastatic relapse | Local and metastatic relapse evaluated by radiological exams (Echo-mammography and MRI) | from surgery up to 5 years |
| Quality of life in post-operative at 4 months and at 1 year and patient satisfaction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BANNIER Marie, MD, PhD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli-Calmettes | Marseille | Bouches-du-Rhône | 13273 | France | ||
| Institut Paul Papin |
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| Label | URL |
|---|---|
| Institut paoli-calmettes | View source |
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| Chemotherapy | Drug | Chemotherapy treatment |
|
|
| Radiation therapy | Radiation | Radiation therapy |
|
Quality of life evaluated by questionnaire QLQ-C30
| Before surgery, at day 21, at 6 months and at 12 months |
| Rate of post-operative complications | Post operative complications evaluated by clinical exam | from surgery up to 1 month |
| Quality of life in post-operative at 4 months and at 1 year and patient satisfaction | Quality of life evaluated by questionnaire QLQ-BR23 | Before surgery, at day 21, at 6 months and at 12 months |
| Quality of life in post-operative at 4 months and at 1 year and patient satisfaction | Quality of life evaluated by questionnaire BREAST-Qtm satisfaction | Before surgery, at day 21, at 6 months and at 12 months |
| Angers |
| France |
| Polyclinique Urbain V | Avignon | France |
| Capio-Clinique Belharra | Bayonne | France |
| Institut Bergonie | Bordeaux | France |
| Centre Jean Perrin | Clermont-Ferrand | France |
| Institut Oscar Lambret | Lille | France |
| Clinique Clementville | Montpellier | France |
| Icm - Institut Regional Du Cancer de Montpellier | Montpellier | France |
| Institut Jean Godinot | Reims | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D018943 | Anthracyclines |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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