Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer
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.
Drug: Letrozole - Concomitant
Drug: Letrozole - Sequential
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Sub-cutaneous late toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Early toxicity
- Lung late toxicity
- Cosmetic results
- Local failure
- Relapse-free survival
- Overall survival
|Study Start Date:||January 2005|
|Study Completion Date:||February 2007|
Letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy.
|Drug: Letrozole - Concomitant|
Letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy.
|Drug: Letrozole - Sequential|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208273
|CRLC Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||David AZRIA, MD,PhD||CRLC Val d'Aurelle|