None listed
Conditions
Interventions
Tamoxifen 20 mg daily for the remainder of the 5 year period.
Group name:Arm B Type of group
Exemestane 25 mg daily for the remainder of the 5 year period.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • be postmenopausal, as defined by any patient > 56 and amenorrhoea for > 2 years or radiation menopause (at least 3 months previously) or surgical oophorectomy or natural amenorrhoea >1 year at breast cancer diagnosis • be receiving tamoxifen and have been treated with tamoxifen for between 2 and 3 years (dose = 20mg/d, unless otherwise agreed with Pharmacia & Upjohn by the collaborating group before joining the study) • remain free from disease following treatment for primary disease • have adequate haematological, renal and hepatic function (defined as normal Hb, WBC > 4.0x10 9 / L. Creatinine < 1.5 UNL. and SGOT < 2.5 UNL) • be accessible for follow-up for the duration of the trial • have given written Informed consent. This format must be according to the local Ethics Committee (Institutional Review Board - IRB) and must be obtained prior to randomisation.
Exclusion criteria
Exclusion criteria: • Unresectable breast cancer • ER negative primary tumour • Evidence of local relapse or distant metastasis (on chest x-ray, scintigraphic bone scanning and liver ultrasonography/CT scanning) at any time • Significant skeletal, cardiac or endocrine disorders • Psychiatric or addictive disorders which could preclude obtaining informed consent • Have received hormone replacement therapy (HRT) within 4 weeks of randomisation • Concomitant treatment with systemic corticosteroids for a prolonged period • Clinical evidence of severe osteoporosis and/or history of osteoporotic fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Survival one year after completion of trial therapy without signs or symptoms Measure:Disease-Free Survival Timepoints:1 year ; Outcome name:Survival one year after completion of trial therapy Measure:Overall Survival Timepoints:1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Mammogram Measure:Incidence of second breast cancer (In contralateral breast) Timepoints:On months 12, 24, 36, and 48 ; Outcome name:Clinical examination and registry of adverse events Measure:Long term tolerability Timepoints:On months 1, 3, 6, 9, 12, 18, 24, 30. 36, 48 | — |
Outcome results
None listed