Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00208273
- Lead Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Letrozole - Sequential Letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy. A Letrozole - Concomitant Letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy.
- Primary Outcome Measures
Name Time Method Sub-cutaneous late toxicity 2 years
- Secondary Outcome Measures
Name Time Method Cosmetic results Overall survival Lung late toxicity Local failure Relapse-free survival Early toxicity
Trial Locations
- Locations (1)
CRLC Val d'Aurelle
🇫🇷Montpellier, France
CRLC Val d'Aurelle🇫🇷Montpellier, France