Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00208273|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 18, 2007
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Letrozole - Concomitant Drug: Letrozole - Sequential||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2005|
|Actual 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|
- Sub-cutaneous late toxicity [ Time Frame: 2 years ]
- Early toxicity
- Lung late toxicity
- Cosmetic results
- Local failure
- Relapse-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208273
|CRLC Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||David AZRIA, MD,PhD||CRLC Val d'Aurelle|