Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Collaborator: Novartis
• Treatments: Letrozole

Criteria

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).