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 - IDEAL - Investigation on the Duration of Extended Adjuvant Letrozole treatment
- Conditions
- breast cancerMedDRA version: 8.1Level: PTClassification code 10057654Term: Breast cancer female
- Registration Number
- EUCTR2006-003958-16-NL
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
- written informed consent
- postmenopausal women
- histologically proven invasive adenocarcinoma of the breast adequately treated at the time of diagnosis without metastases
- ER and/or PgRpositive breast cancer
- completed planned adjuvant endocrine therapy with tamoxifen, aromatase inhibitors or a sequence of both ( provided tamoxifen was given upfront in latter case)
- no evidence of breast cancer recurrence including contralateral breast cancer at the time of randomization
- WHO performance status 0, 1 or 2
- adjuvant endocrine treatment completed for no longer than 2 years (with a tolerance window of 6 weeks)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- ER and PgR negative or unknown primary tumors
- evidence of local or distant breast cancer recurrence
- untreated hyperlipidemia
- concurrent use of other aromatase inhibitors
- concurrent (experimental) chemotherapy
- any use of HRT or SERMS
- previous or concomitant malignancy (not breast cancer) within the past 5 years
- other non-malignant systemic diseases which would prevent prolonged follow-up
- patients with a known history of HIV
- severe physical or psychological concomitant diseases
- uncontrolled seizure disorders associated with falls
- patients treated with systemic investigational drugs and/or devices within the past 30 days or topical investigational drugs within the past 7 days
- history of non-compliance to medical treatment
- mental illness that precludes the patient from giving informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 years;Secondary Objective: to compare te efficacy of 2.5 vs. 5 years of extended adjuvant letrozole with respect to:<br>- overall survival<br>- distant disease free survival<br>- contralateral breast cancer<br>- safety;Primary end point(s): disease free survival (DFS) defined as the time from randomization to the first date of local, regional or distant relapse, second primary breast cancer (including contralateral breast cancer), or death of any cause
- Secondary Outcome Measures
Name Time Method