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

Phase II Study: Assessing 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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01199354

Acronym

M-RIC

Enrollment

Registered

2010-09-10

Start date

2010-07-31

Completion date

2017-07-31

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

Keywords

Invasive breast carcinoma

Brief summary

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.

Interventions

PROCEDUREMastectomy, 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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...

Design outcomes

Primary

Measure	Time frame	Description
Incidence of skin necrosis	—	To evaluate the incidence of skin necrosis in case of treatment with skin sparing mastectomy and immediate breas reconstruction with latissimus dorsi myocutaneous flap after neoadjuvant chemotherapy and radiotherapy.

Secondary

Measure	Time frame
Rate of histological remission of the surgical specimen based on the anatomopathological examination	—

Countries

France

Contacts

Primary ContactMagali Lacroix

m.lacroix@millenaire.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026