E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study examines the influence of pharmacogenetic markers on the efficacy and side effects in postmenopausal, steroid hormone positive breast cancer patients, who are treated with Letrozol. The patients are eligible if a new treatment with letrozole is planed. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
•Disease free survival in association with tested genotypes (whole genome scan) |
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E.2.2 | Secondary objectives of the trial |
•Overall survival in association with tested genotypes (whole genome scan) •Quality of life in association with tested genotypes (whole genome scan)´
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
•Health economy in the use of aromatase inhibitors (subprotocol A)
•Identification of genetic susceptibility markers for hormonal receptor positive breast cancer (subprotocol B)
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E.3 | Principal inclusion criteria |
•Indication for adjvuant antihormonal treatment of breast cancer •Age ≥ 18 years •Histological proven hormonal receptor positive breast cancer •No evidence of distant breast cancer disease •Patient must be postmenopausal •Postmenopausal is defined as one of the following criteria •Age above 55 years •Age ≤55 years, but no spontaneous menstruation since 12 months •Age ≤55 years and postmenopausal gonadotropin levels (luteinizing Hormone and follicle-stimulating hormone >40 IU/L) •Bilateral Oophorectomy •Life expectancy greater than 12 months •ECOG performance Status of at least 0, 1 or 2. •Patients should be able to be compliant to the study procedures •Signed informed consent
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E.4 | Principal exclusion criteria |
•Patients who have no indication for an aromatase inhibitor or have a known hypersensitivity to letrozole •Prior treatment with letrozole other aromatase inhibitors •Evidence of distant metastastatic breast cancer disease •Unstable or serious co-existing medical condition, including potentially serious infection that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with the patient’s safety or informed consent. (No specific tests are required for confirmation of egilibility) •Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin’s disease or non-Hodgkin-lymphoma, provided 5 years have elapsed from completion of therapy, and there has been no recurrence •Patients with unstable angina, or uncontrolled cardiac disease (e.g. Class III and IV New York Heart Association’s Functional Classification) or uncontrolled endocrine disorders. •Instabiler Diabetes mellitus •Other antihormonal investigational or non-investigational drugs within the past 30 days and the concomitant use of investigational or non-investigational drugs except trastuzumab in the adjuvant treatment of HER2 positive breast cancer •Male patients •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point of the study is the collection and analysis of biomaterials (tumour tissue, DNA, serum) of patients with an endocrine-responsive breast cancer to evaluate predictive markers by examination of_ - genomic DNA, - gene expresssion (RNA), - proteins. The knowledge about further predictive marker shall help to optimize the treatment with aromatase inhibitors in breast cancer patients. |
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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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
quality of life, compliance |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 90 |
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
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End of trial is 60 months after the last inclusion of the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |