NCT00208273

Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will compare grade 2 or greater late skin toxicities of concomitant letrozole-radiotherapy and radiotherapy followed by letrozole as adjuvant therapy for postmenopausal women with receptor (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\]) positive tumors. Each drug will be prescribed for 5 years.

Detailed description

This trial is an open-label randomized multicenter phase II study. A ratio of 1 to 1 will be used for the randomization process between the two arms: * Arm A : Letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy. * Arm B : Letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy. All patients will be followed every 3 months for toxicities, disease status and for survival until death.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole - Concomitant
DRUG	Letrozole - Sequential

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-01-01
• Completion: 2007-02-01
• First posted: 2005-09-21
• Last updated: 2021-06-02

Locations

1 site across 1 country: France