Phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer
- Conditions
- Postmenopausal patients with breast cancer
- Registration Number
- JPRN-UMIN000004458
- Lead Sponsor
- International Breast Cancer Study Group
- Brief Summary
From the current analysis, we conclude that extended treatment with intermittent letrozole did not improve disease-free survival versus treatment with continuous letrozole. The safety, quality-of-life, and efficacy results of the intermittent administration provide clinically relevant information about extended adjuvant endocrine therapy with letrozole and support the safety of this option for temporary treatment breaks in selected patients who might require them.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 4884
Not provided
1. Patients must have clinically adequate hepatic function. 2. Patients who have had a bone fracture due to osteoporosis at any time during the 4-6 years of prior endocrine SERM/AI therapy. 3. Patients who have had any previous or concomitant malignancy EXCEPT adequately treated: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma. 4. Patients who have had any other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up. 5. Patients with psychiatric, addictive, or any disorder which compromises compliance with protocol requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS): time from randomization to local (including invasive recurrence restricted to the breast after breast conserving treatment), regional or distant relapse, contralateral breast cancer, appearance of a second (non-breast) malignancy, or death from any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Overall survival (OS), distant disease-free survival (DDFS), breast cancer free interval (BCFI), sites of first failure, second (non-breast) malignancies, deaths without prior cancer events, and adverse events.