Histological Response Rate After Mastectomy & Immediate Breast

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Breast Cancer

Clinical Trial Details

NCT number	NCT02679040
Study type	Interventional
Source	Institut Paoli-Calmettes
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	January 27, 2016
Completion date	February 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms