breast cancer, post-menopausal, aromatase inhibitor, letrozole, extended hormonal therapy mamma carcinoom, aromatase remmer, verlengde hormonale therapie
Conditions
Interventions
1. 2.5 years letrozole
2. 5 years letrozole.
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Postmenopausal at the time of randomization; 2. Histologically proven invasive breast cancer (stage I, II, or III) adequately treated at the time of diagnosis; 3. ER and/or PgR positive breast cancer; 4. Completed 5 year (± 3 months) adjuvant endocrine therapy with either tamoxifen for 5 years, aromatase inhibitors for 5 years or a sequence of both (provided that tamoxifen was given upfront for 2-3 years); 5. No evidence of breast cancer recurrence including contralateral breast cancer at the time of randomization; 6. WHO performance status 0, or 1; 7. Adjuvant endocrine treatment completed for no longer than 2 years (with a tolerance window of 3 months); 8. Accessible for follow-up for the duration of the trial; 9. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. ER and PgR negative or unknown primary tumors; 2. Evidence of previous or current localized or distant breast cancer recurrence; 3. Bilateral breast cancer and/or (preventive) bilateral mastectomy; 4. Untreated hyperlipidemia (total cholesterol ≥ 7.75 mmol/L, triglycerides ≥ 2.5 x ULN); 5. Concurrent use of other aromatase inhibitors; 6. Concurrent chemotherapy; 7. 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; 8. Previous or concomitant malignancy within the past 5 years (except adequately treated basal or squamous cell carcinoma of the skin or CIS of the cervix). Patients with a malignancy in their history more than 5 years ago must be disease free at least for 5 years. Patients with a history of breast cancer, other than the breast cancer under study are always excluded; 9. 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; 10. Patients with a known history of HIV; 11. 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; 12. Uncontrolled seizure disorders associated with falls; 13. 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; 14. History of non-compliance to medical treatment and patients considered potentially unreliable; 15. Mental illness that precludes the patient from giving informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival; 2. Distant disease free survival; 3. Contralateral breast cancer; 4. Safety. | — |
Contacts
Public ContactC.J.H. Velde, van de
Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600
Outcome results
None listed