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. (MARTA)

Institut Claudius Regaud

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer Invasive

Treatments: Other: Patients with invasive breast cancer will receive:

Study type: Interventional

Funder types: Other

Identifiers

NCT03627988

18 SEIN 11

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Patients with breast cancer

Experimental group

Treatment:

Other: Patients with invasive breast cancer will receive: