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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-22

No results posted yet for this study

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

PROCEDURE

Mastectomy 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 & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-07
Primary Completion
2026-05-18
Completion
2026-05-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03627988 on ClinicalTrials.gov