Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Letrozole - Concomitant

Drug: Letrozole - Sequential

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00208273

CO-HO-RT/2004/31

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).