An open label, randomized phase III trial comparing 2.5 year duration of letrozole (Femara) treatment with 5 year duration in patients previously treated for endocrine sensitive early breast cancer
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON39762
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1824
• 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Disease free survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Overall survival<br /><br>• Distant disease free survival<br /><br>• Contralateral breast cancer<br /><br>• Safety.</p><br>