Breast Cancer
Conditions
Keywords
Postmenopausal breast cancer, radiohormonotherapy sequences, ER+ and/or PgR+,, Postmenopausal Breast cancer,, Adjuvant setting
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.
Interventions
DRUGLetrozole - Concomitant
DRUGLetrozole - Sequential
Sponsors
Novartis
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sub-cutaneous late toxicity | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Lung late toxicity | — |
| Cosmetic results | — |
| Early toxicity | — |
| Relapse-free survival | — |
| Overall survival | — |
| Local failure | — |
Countries
France
Outcome results
None listed