Clinical trial NCT02679040: Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy
Official title: Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of histological response of an infiltrating tumor within various molecular subgroups
timeFrame: from surgery up to 1 month
Secondary outcomes:
measure: Rate of ganglionar response on the axillary lymph nodes after chemotherapy and radiotherapy néoadjuvant
timeFrame: from surgery up to 1 month
Other outcomes:
measure: Rate of local and metastatic relapse
timeFrame: from surgery up to 5 years
measure: Quality of life in post-operative at 4 months and at 1 year and patient satisfaction
timeFrame: Before surgery, at day 21, at 6 months and at 12 months
measure: Rate of post-operative complications
timeFrame: from surgery up to 1 month
measure: Quality of life in post-operative at 4 months and at 1 year and patient satisfaction
timeFrame: Before surgery, at day 21, at 6 months and at 12 months
measure: Quality of life in post-operative at 4 months and at 1 year and patient satisfaction
timeFrame: Before surgery, at day 21, at 6 months and at 12 months
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du-Rhône
city: Angers
country: France
facility: Institut Paul Papin
city: Avignon
country: France
facility: Polyclinique Urbain V
city: Bayonne
country: France
facility: Capio-Clinique Belharra
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lille
country: France
facility: Institut Oscar Lambret
city: Montpellier
country: France
facility: Clinique Clementville
city: Montpellier
country: France
facility: Icm - Institut Regional Du Cancer de Montpellier
city: Reims
country: France
facility: Institut Jean Godinot
Study officials:
affiliation: Institut Paoli-Calmettes
name: BANNIER Marie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: