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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Radiation therapy; Procedure: Immediate mammary reconstruction; Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Institut Paul Papin
  • Avignon, France
    • Polyclinique Urbain V
  • Bayonne, France
    • Capio-Clinique Belharra
  • Bordeaux, France
    • Institut Bergonie
  • Clermont-Ferrand, France
    • Centre Jean Perrin
  • Lille, France
    • Institut Oscar Lambret
  • Montpellier, France
    • Clinique Clémentville
  • Montpellier, France
    • Icm - Institut Regional Du Cancer de Montpellier
  • Reims, France
    • Institut Jean Godinot
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13273
      • Institut Paoli-Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: BANNIER Marie, MD, PhD, Institut Paoli-Calmettes

Publications and helpful links

Helpful Links

• Institut paoli-calmettes

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2016
• Primary Completion (Actual): March 29, 2021
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimated): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: HIST-RIC-IPC 2014-014