NCT01199354
Unknown
Phase 2
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.
Clinique Clementville9 sites in 1 country80 target enrollmentJuly 2010
ConditionsBreast Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Carcinoma
- Sponsor
- Clinique Clementville
- Enrollment
- 80
- Locations
- 9
- Primary Endpoint
- Incidence of skin necrosis
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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...
Outcomes
Primary Outcomes
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 Outcomes
- Rate of histological remission of the surgical specimen based on the anatomopathological examination
Study Sites (9)
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