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

NCT02679040 | Unknown Phase 2 DMC

• 1 other identifier: HIST-RIC-IPC 2014-014
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 10

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of ganglionar response on the axillary lymph nodes after chemotherapy and radiotherapy néoadjuvant

  from surgery up to 1 month

Other Outcomes (5)

• Rate of local and metastatic relapse

  from surgery up to 5 years

• Quality of life in post-operative at 4 months and at 1 year and patient satisfaction

  Before surgery, at day 21, at 6 months and at 12 months

• Rate of post-operative complications

  from surgery up to 1 month

Study Arms (1)

Immediate Mammary Reconstruction

EXPERIMENTAL

Chemotherapy, radiation therapy, mastectomy with immediate mammary reconstruction

Procedure: Immediate mammary reconstruction; Drug: Chemotherapy; Radiation: Radiation therapy

Interventions

Immediate mammary reconstruction PROCEDURE

Chemotherapy administration then radiotherapy and then surgery : mastectomy and immediate mammary reconstruction.

Immediate Mammary Reconstruction

Chemotherapy DRUG

Chemotherapy treatment

Also known as: anthracyclines and taxotere with or without Herceptin

Immediate Mammary Reconstruction

Radiation therapy RADIATION

Radiation therapy

Immediate Mammary Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years,
• Infiltrating carcinoma,
• Neoadjuvant chemotherapy indication,
• Radiotherapy indication,
• or 1 score Performance status (WHO),
• Signed informed consent,
• Affiliation to Social Security System

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (10)

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, 13273, France

Location

Institut Paul Papin

Angers, France

Location

Polyclinique Urbain V

Avignon, France

Location

Capio-Clinique Belharra

Bayonne, France

Location

Institut Bergonie

Bordeaux, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Institut Oscar Lambret

Lille, France

Location

Clinique Clementville

Montpellier, France

Location

Icm - Institut Regional Du Cancer de Montpellier

Montpellier, France

Location

Institut Jean Godinot

Reims, France

Location

Related Links

• Institut paoli-calmettes

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy; Anthracyclines; Docetaxel; Trastuzumab; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• BANNIER Marie, MD, PhD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 10, 2016
• Study Start: January 27, 2016
• Primary Completion: March 29, 2021
• Study Completion: February 1, 2025
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

FR (10)