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.

NCT03627988 | Active Not Recruiting Phase 2

• 1 other identifier: 18 SEIN 11
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Invasive

Keywords

Breast Cancer Invasive; TomoTherapy; Immediate prosthetic breast reconstruction

Outcome Measures

Primary Outcomes (1)

• Rate of patients with successful mastectomy strategy by immediate reconstruction.

  12 months for each patient

Secondary Outcomes (6)

• 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

Study Arms (1)

Patients with breast cancer

EXPERIMENTAL

Other: Patients with invasive breast cancer will receive:

Interventions

Patients with invasive breast cancer will receive: OTHER

* Mastectomy with Immediate prosthetic breast reconstruction * Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).

Patients with breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (2)

Institut Bergonie

Bordeaux, France

Location

Institut Universitaire Du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 14, 2018
• Study Start: June 7, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

FR (2)