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. MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Femara
Product Name: Femara
Product Code: Letrozole
Pharmaceutical Form: Tablet
INN or Proposed INN: LETROZOLE
CAS Number: 112809515
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Institut für Frauengesundheit GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Disease free survival in association with tested genotypes (whole genome scan);Secondary Objective: •Overall survival in association with tested genotypes (whole genome scan) •Quality of life in association with tested genotypes (whole genome scan)´ ;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. | — |
Countries
Germany
Outcome results
None listed