NCT03627988

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.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Patients with invasive breast cancer will receive:	* Mastectomy with Immediate prosthetic breast reconstruction * Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).

Timeline

• Start date: 2019-06-07
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2018-08-14
• Last updated: 2025-07-31

Locations

2 sites across 1 country: France