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

Phase 2

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Immediate mammary reconstruction; Drug: Chemotherapy; Radiation: Radiation therapy

• Registration Number: NCT02679040
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-25
• Study Start: 2016-01-27
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Primary Completion: 2021-03-29
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immediate Mammary Reconstruction	Immediate mammary reconstruction	Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction
Immediate Mammary Reconstruction	Radiation therapy	Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction
Immediate Mammary Reconstruction	Chemotherapy	Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction

Primary Outcome Measures

Name	Time	Method
Rate of histological response of an infiltrating tumor within various molecular subgroups	from surgery up to 1 month	Tumor Histological response (group RH+ Her2+, group RH+ Her2-, group RH- Her2+, and group RH- Her2-)

Secondary Outcome Measures

Name	Time	Method
Rate of ganglionar response on the axillary lymph nodes after chemotherapy and radiotherapy néoadjuvant	from surgery up to 1 month	Number of lymph nodes collected and number of positive lymph nodes

Trial Locations

Locations (10)

Institut Bergonie; 🇫🇷 Bordeaux, France

Icm - Institut Regional Du Cancer de Montpellier; 🇫🇷 Montpellier, France

Institut Oscar Lambret; 🇫🇷 Lille, France

Capio-Clinique Belharra; 🇫🇷 Bayonne, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, Bouches-du-Rhône, France

Institut Paul Papin; 🇫🇷 Angers, France

Polyclinique Urbain V; 🇫🇷 Avignon, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Clinique Clementville; 🇫🇷 Montpellier, France

Institut Jean Godinot; 🇫🇷 Reims, France