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

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Letrozole

About this trial

This is an interventional treatment trial for is to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Frauenklinik University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Letrozol

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease free survival in association with tested genotypes (whole genome scan)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01908556

First Posted

July 23, 2013

Last Updated

July 24, 2013

Sponsor

Institut fuer Frauengesundheit

Collaborators

Novartis, ClinSol

1. Study Identification

Unique Protocol Identification Number

NCT01908556

Brief Title

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

Acronym

PreFace

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut fuer Frauengesundheit

Collaborators

Novartis, ClinSol

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3545 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Letrozol

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Letrozole

Primary Outcome Measure Information:

Title

Disease free survival in association with tested genotypes (whole genome scan)

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Facility Information:

Facility Name

Frauenklinik University Hospital

City

Erlangen

State/Province

Bavaria

ZIP/Postal Code

91054

Country

Germany

12. IPD Sharing Statement

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

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