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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.


Phase 2
18 Years
75 Years
Open (Enrolling)
Female
Breast Carcinoma

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Trial Information

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.


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...

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Incidence of skin necrosis

Outcome Description:

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.

Principal Investigator

Cécile Zinzindhoue

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinique Clementville

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CLEM-01

NCT ID:

NCT01199354

Start Date:

July 2010

Completion Date:

July 2017

Related Keywords:

  • Breast Carcinoma
  • Invasive breast carcinoma
  • Breast Neoplasms
  • Carcinoma

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