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

June 30, 2023 updated by: Institut Paoli-Calmettes

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Clementville
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: from surgery up to 1 month
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
Time Frame: from surgery up to 1 month
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
Time Frame: from surgery up to 5 years
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
Time Frame: Before surgery, at day 21, at 6 months and at 12 months
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
Time Frame: from surgery up to 1 month
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
Time Frame: Before surgery, at day 21, at 6 months and at 12 months
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
Time Frame: Before surgery, at day 21, at 6 months and at 12 months
Quality of life evaluated by questionnaire BREAST-Qtm satisfaction
Before surgery, at day 21, at 6 months and at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • HIST-RIC-IPC 2014-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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