Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Immediate mammary reconstruction
* Drug: Chemotherapy
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years, Infiltrating carcinoma, Neoadjuvant chemotherapy indication, Radiotherapy indication, 0 or 1 score Performance status (WHO), Signed informed consent, Affiliation to Social Security System Exclusion Criteria: Lobular carcinoma, Luminal A Tumor (RH+ and Her2 negative with grade I, and tumor RH+ Her2 negative with grade II and with Ki67<20%), Attempt of first conservative treatment, Metastatic breast cancer, Inflammatory carcinoma, History of homolateral or controlateral mammary carcinoma, Progression disease (despite neoadjuvant chemotherapy), Contraindications in an immediate mammary reconstruction by scrap of big dorsal (comorbidity), Any psychological, familial, sociological or geographical condition-potentially hampering compliance with the study protocol or follow-up schedule, Patients deprived of liberty or placed under the authority of a tutor.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Mammary Reconstruction<br>Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction | Procedure: Immediate mammary reconstruction<br>* Chemotherapy administration then radiotherapy and then surgery : mastectomy and immediate mammary reconstruction.<br>Drug: Chemotherapy<br>* Chemotherapy treatment<br>* Other names: anthracyclines and taxotere with or without Herceptin;Radiation: Radiation therapy<br>* Radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |