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

Breast Cancer Clinical Trial

— HIST-RIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02679040
• Other study ID #: HIST-RIC-IPC 2014-014
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 27, 2016
• Est. completion date: February 2025

Study information

• Verified date: June 2023
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: February 2025
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Drug:
• Chemotherapy
Chemotherapy treatment

Radiation:
• Radiation therapy
Radiation therapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of local and metastatic relapse	Local and metastatic relapse evaluated by radiological exams (Echo-mammography and MRI)	from surgery up to 5 years
Other	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
Other	Rate of post-operative complications	Post operative complications evaluated by clinical exam	from surgery up to 1 month
Other	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
Other	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
Primary	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	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

External Links

•   Institut paoli-calmettes