Breast Cancer Invasive
Conditions
Keywords
Breast Cancer Invasive, TomoTherapy, Immediate prosthetic breast reconstruction
Brief summary
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.
Interventions
PROCEDUREMastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy
* Mastectomy with Immediate prosthetic breast reconstruction * Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Patient with a non-inflammatory and non-metastatic invasive mammary carcinoma. 3. Indication of mastectomy and immediate prosthetic breast reconstruction. 4. Patient wishing to have an immediate mammary reconstruction with prosthesis. 5. Formal or presumptive pre-operative indication for adjuvant radiotherapy (+/- chemotherapy). 6. OMS ≤ 2. 7. Patient affiliated to a Social Health Insurance in France. 8. Patient must provide written informed consent prior to any study specific procedures.
Exclusion criteria
1. Metastatic breast cancer. 2. Bilateral breast cancer. 3. Inflammatory breast cancer (T4d). 4. History of breast cancer within 5 years. 5. Not applicable according to the protocol version N°6 : Previous neoadjuvant treatment for the ongoing disease. 6. Pregnant or breastfeeding women. 7. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure. 8. Patient protected by law.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with successful mastectomy strategy by immediate reconstruction. | 12 months for each patient |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed