Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2017-07-31

Brief Summary

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The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.

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Detailed Description

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Conditions

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Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.

Mastectomy, preservation of the skin envelope, removal of the nipple-areolar complex and dissection of the axillary lymph nodes followed by immediate reconstruction with autologous latissimus dorsi flap with or without prosthesis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women \< 75 year old
* Invasive breast carcinoma, indication for mastectomy
* Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier...

Exclusion Criteria

* Women older than 75
* Metastatic breast carcinoma
* Antecedents of previously treated homolateral breast carcinoma
* Documented cancer progression
* Smoker at the moment of the indication surgery
* Known diabetes, neoadjuvant hormonal treatment...

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Clinique Clementville

Principal Investigators

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Cécile Zinzindhoue

Role: PRINCIPAL_INVESTIGATOR

Clinique Clementville

Locations

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