Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Pr… (NCT03627988) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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.
France65 participantsStarted 2019-06-07
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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).
What they're measuring
1
Rate of patients with successful mastectomy strategy by immediate reconstruction.
✕. 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.