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

C

Clinique Clementville

Status and phase

Unknown
Phase 2

Conditions

Breast Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01199354
CLEM-01

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No 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...

Trial contacts and locations

9

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Central trial contact

Magali Lacroix

Data sourced from clinicaltrials.gov

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