E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
to compare te efficacy of 2.5 vs. 5 years of extended adjuvant letrozole with respect to: - overall survival - distant disease free survival - contralateral breast cancer - safety |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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) |
|
E.4 | Principal exclusion criteria |
- 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 |
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 40 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |