Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy +/-Chemotherapy. Patients with non-inflammatory and non-metastatic invasive mammary carcinoma will be included in this study. The study procedure will be a surgical treatment by mastectomy with immediate prosthetic breast reconstruction followed by an adjuvant therapy: TomoTherapy +/-Chemotherapy (radiation therapy alone or preceded by chemotherapy). The nature of the chemotherapy treatment will be decided according to the standards of each center. The patients will be followed for the study up to 36 months after the surgical procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
* Mastectomy with Immediate prosthetic breast reconstruction * Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).
Institut Bergonie
Bordeaux, France
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, France
Rate of patients with successful mastectomy strategy by immediate reconstruction.
Time frame: 12 months for each patient
Quality of the radiotherapy treatment plan (dosimetry).
Time frame: 78 months for all patients
Progression-free survival.
Time frame: 36 months for each patient
Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
Time frame: 36 months for each patient
Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
Time frame: 36 months for each patient
Quality of Life assessed using the questionnaire called "Breast-Q".
Time frame: 36 months for each patient
Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.
Time frame: 36 months for each patient
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