breast cancer
Conditions
Interventions
Letrozole treatment 2,5 or 5 years.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Postmenopausal at the time of randomization (definition: see section 2.4.) • Histologically proven invasive breast carcinoma (stage I, II or III), adequately treated at the time of diagnosis • ER and/or PgR positive breast cancer, defined according to local laboratory definitions • Completed 5 year (± 3 months) adjuvant endocrine therapy with either tamoxifen for 5 years, aromatase inhibitor(s) for 5 years AIs or as a sequence of both (provided that tamoxifen was given upfront for 2-3 years) • No evidence of breast cancer recurrence at the time of randomization • WHO performance status 0 or 1 (see Appendix 2) • Adjuvant endocrine treatment completed for no longer than 2 years (with a tolerance window of 3 months) • Accessible for follow-up for the duration of the trial • Written informed consent
Exclusion criteria
Exclusion criteria: • ER and PgR negative or unknown primary tumors • Evidence of previous or current localized or distant breast cancer recurrence • Bilateral breast cancer and/or (preventive) bilateral mastectomy • Untreated hyperlipidemia (total cholesterol >= 7.75 mmol/L, triglycerides >= 2.5 x ULN) • Concurrent use of other aromatase inhibitors • Concurrent chemotherapy • Any use of HRT or SERMS. Patients on HRT and willing to participate in the trial will have to discontinue HRT 4 weeks prior to randomization. Topical estrogens are DISCOURAGED during the trial. • Previous or concomitant malignancy (other than breast cancer) within the past 5 years (exceptEXCEPT adequately treated basal or squamous cell carcinoma of the skin or CIS of the cervix). Patients with a other malignancy in their history more than 5 years ago must be disease free for 5 years. Patients with a history of breast cancer, other than the breast cancer under study are always excluded. • Other non-malignant systemic diseases including uncontrolled infections, uncontrolled DM-II, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. • Patients with a known history of HIV • Severe concomitant physical or psychological diseases that might impair compliance or assessment of drug/patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG • Uncontrolled seizure disorders associated with falls • Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days • History of non-compliance to medical treatment and patients considered potentially unreliable • Mental illness that precludes the patient from giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall survival • Distant disease free survival • Contralateral breast cancer • Safety. | — |
Countries
Netherlands
Outcome results
None listed