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Evaluation of Predictive Factors Regarding the Effectivity of Aromatase Inhibitor Therapy (PreFace) (PreFace)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01908556
Recruitment Status : Unknown
Verified February 2009 by Institut fuer Frauengesundheit.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Information provided by (Responsible Party):
Institut fuer Frauengesundheit

Tracking Information
First Submitted Date  ICMJE July 23, 2013
First Posted Date  ICMJE July 25, 2013
Last Update Posted Date July 25, 2013
Study Start Date  ICMJE February 2009
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2013)
Disease free survival in association with tested genotypes (whole genome scan) [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2013)
Overall survival in association with tested genotypes Quality of life in association with tested genotypes Health economy in the use of aromatase inhibitors Identification of genetic susceptibility markers for hormonal receptor positive breast cancer [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluation of Predictive Factors Regarding the Effectivity of Aromatase Inhibitor Therapy (PreFace)
Official Title  ICMJE Open Labeled, Propective, Multicentric Phase IV Study to Examine the Influence of Pharmacogenetic Markers on the Efficacy and Side Effects in Postmenopausal, Steroid Hormone Positive Breast Cancer Patients, Who Are Treated With Letrozol.
Brief Summary

Aromatase inhibitors have shown a superior efficacy compared to tamoxifen in the treatment of hormonal receptor positive breast cancer in postmenopausal patients.

Side effects like osteoporosis, bone fractures and muscle/bone pain are however more frequent using of aromatase inhibitors compared with tamoxifen. These side effects compromise the patients' well being in a significant way and may favour the use of Tamoxifen in clinical practice.

Furthermore there is evidence that polymorphisms in the CYP2D6 Gene might be associated with an improved efficacy of Tamoxifen that is equieffective to aromatase inhibitors.

Concerning the pharmacogenetics of aromatase inhibition there are known polymorphisms of the CYP19A1 gene that are associated with altered peripheral sex hormone levels and altered prognosis in breast cancer patients. One study could even associate a polymorphism in the CYP19A1 gene with a prolonged time to progression in patients with metastatic breast cancer who have been treated with letrozol.

Therefore the aim of this study is to identify biomarkers that could predict the efficacy of an adjuvant Letrozol treatment in postmenopausal breast cancer patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE is to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients.
Intervention  ICMJE Drug: Letrozole
Study Arms  ICMJE Experimental: Letrozol
All patients are treated with letrozole 2.5 mg for 5 years for the adjuvant treatment of postmenopausal patients with a hormone receptor positive primary breast cancer. Patients are treated according to the authorities' approval of the drug. Of all patients a germline DNA sample will be obtained before the treatment starts and serum samples will be taken at months 0, 6 and 12. Furthermore the paraffin embedded tissue block will be sent to a central pathology laboratory for central assessment of tumor biomarkers.
Intervention: Drug: Letrozole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 24, 2013)
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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, see Appendix 9) or uncontrolled endocrine disorders.
  • Instabiler Diabetes mellitus; insulinpflichtiger Typ II Diabetes
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01908556
Other Study ID Numbers  ICMJE TRAFO-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut fuer Frauengesundheit
Study Sponsor  ICMJE Institut fuer Frauengesundheit
Collaborators  ICMJE
  • Novartis
  • ClinSol
Investigators  ICMJE Not Provided
PRS Account Institut fuer Frauengesundheit
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP