Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.

Conditions
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Breast Cancer Invasive

Intervention / Treatment
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* Other: Patients with invasive breast cancer will receive:


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Patient with a non-inflammatory and non-metastatic invasive mammary carcinoma. Indication of mastectomy and immediate prosthetic breast reconstruction. Patient wishing to have an immediate mammary reconstruction with prosthesis. Formal or presumptive pre-operative indication for adjuvant radiotherapy (+/- chemotherapy). OMS ≤ 2. Patient affiliated to a Social Health Insurance in France. Patient must provide written informed consent prior to any study specific procedures. Exclusion Criteria: Metastatic breast cancer. Bilateral breast cancer. Inflammatory breast cancer (T4d). History of breast cancer within 5 years. Not applicable according to the protocol version N°6 : Previous neoadjuvant treatment for the ongoing disease. Pregnant or breastfeeding women. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure. Patient protected by law.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with breast cancer<br> | Other: Patients with invasive breast cancer will receive:<br>* Mastectomy with Immediate prosthetic breast reconstruction Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with successful mastectomy strategy by immediate reconstruction. |  | 12 months for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of the radiotherapy treatment plan (dosimetry). |  | 78 months for all patients | 
| Progression-free survival. |  | 36 months for each patient | 
| Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03. |  | 36 months for each patient | 
| Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03. |  | 36 months for each patient | 
| Quality of Life assessed using the questionnaire called Breast-Q. |  | 36 months for each patient | 
| Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale. |  | 36 months for each patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Invasive, TomoTherapy, Immediate prosthetic breast reconstruction