Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

Titre officiel

A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

Sommaire:

JUSTIFICATION : La radiothérapie fait appel à des rayons X à haute énergie pour tuer les cellules cancéreuses. L’administration d’une radiothérapie après une chirurgie peut tuer les cellules tumorales qui seraient toujours présentes, et pourrait être un traitement efficace contre le cancer du sein. BUT : Cette étude de phase II vise à déterminer l’efficacité de la radiothérapie dans le traitement de patientes atteintes d’un cancer du sein localement récidivant déjà traité au moyen d’une chirurgie conservatrice du sein.

Description de l'essai

Primary Outcome:

• Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year

Secondary Outcome:

• In-breast recurrence
• Freedom from mastectomy
• Rate of circulating tumour cells
• Overall and 1-year adverse events
• Cosmesis at 1 and 3 years
• Distant metastasis-free survival
• Mastectomy-free survival
• Overall survival

OBJECTIVES:
Primary

• To evaluate skin, breast, and chest wall adverse events occurring within 1 year after completion of 3D-conformal partial-breast re-irradiation following repeat breast-preserving surgery in patients with locally recurrent breast carcinoma.
  

Secondary

• To evaluate the adverse events at 1 year and at any time of this regimen in these patients.

• To evaluate in-breast control rate in patients treated with this regimen.

• To evaluate freedom-from-mastectomy rate in these patients.

• To evaluate the rate of circulating tumour cells (CTCs) in this patient population and to document eradication of CTCs by locoregional therapy.

• To determine whether translational objective will correlate with eradication or presence of CTCs with in-breast recurrence and distant metastasis-free survival.

• To evaluate cosmesis as judged by the patient and independent evaluation.

• To evaluate distant metastasis-free survival, mastectomy-free survival, and overall survival of patients treated with this regimen.

OUTLINE:

This is a multicentre study. Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily, 5 days a week, for 3 weeks. Some patients undergo blood sample collection at baseline and within 3 weeks after completion of radiation therapy for circulating tumour cells analysis. Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following radiation therapy. After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.

Voir cet essai sur ClinicalTrials.gov