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

NCT01908556 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3545

Last updated 2013-07-25

No results posted yet for this study

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.

Conditions

  • is to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients.

Interventions

DRUG

Letrozole

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • ClinSol

    collaborator UNKNOWN

  • Institut fuer Frauengesundheit

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01908556 on ClinicalTrials.gov