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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Paoli-Calmettes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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