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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with breast cancer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with successful mastectomy strategy by immediate reconstruction. | 12 months for each patient |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | France | ||||
| Institut Universitaire Du Cancer de Toulouse - Oncopole |
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| 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 |
| Toulouse |
| 31059 |
| France |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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