Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Letrozole - Concomitant
* Drug: Letrozole - Sequential


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Compliant postmenopausal women Conservative breast cancer surgery Extension evaluation of disease will be proven negative Patients with tumor negative margins Patients will be classified as T1, T2, T3; Sentinel node negative, N0, N1 or N2; M0. Receptor positive tumors (ER and/or PgR = 10 fmol/mg cytosol protein; or = 10% of the tumor cells positive by immunocytochemical evaluation). Adequate marrow function (polynuclear neutrophils >= 1200.10^9/l, platelets >= 100.10^9/l, and hemoglobin >= 10 g/dl). Hepatic function (bilirubin >= 30 µmol/l, ALT (SGPT) or AST (SGOT) >= 1.5 x upper limit of the institution) and cholesterol level <2 x upper limit of the institution. Must be geographically accessible for follow-up. Written and dated informed consent Exclusion Criteria: Patients with distant metastases. Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast. Patients staged T4 or N3 or treated by not conservative surgery (radical mastectomy). Patients with neoadjuvant chemotherapy or hormonal therapy. Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years. Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up. Patients treated with systemic investigational drugs within the past 30 days. Breast cancer chemoprevention with anti-estrogens Hormone replacement therapy (HRT) not stopped at least 4 weeks before randomization Patients known to be HIV positive (no specific tests are required to determine the eligibility).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy. | Drug: Letrozole - Concomitant<br> <br> |
| Experimental: B<br>Letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy. | Drug: Letrozole - Sequential<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-cutaneous late toxicity |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early toxicity |  |  | 
| Lung late toxicity |  |  | 
| Cosmetic results |  |  | 
| Local failure |  |  | 
| Relapse-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal breast cancer, radiohormonotherapy sequences, ER+ and/or PgR+,, Postmenopausal Breast cancer,, Adjuvant setting