is to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients.Phase 4PreFaceNCT01908556
Evaluation of Predictive Factors Regarding the Effectivity of Aromatase Inhibitor Therapy (PreFace)
A Phase 4 study testing Letrozole in people with is to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients., run by Institut fuer Frauengesundheit at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- is to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients.
- What is being tested?
- Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,545 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
- Being tested
- Letrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Letrozol | Experimental | 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. Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival in association with tested genotypes (whole genome scan)
Measured: 5 years
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startFeb 2009
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for is to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, ClinSol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908556
- Sponsor's protocol ID
- TRAFO-001
- Acronym
- PreFace
- Status last verified
- Feb 2009
- First submitted
- 23 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beierlein M, Haberle L, Nabieva N, Maass N, Aktas B, Kummel S, Thomssen C, Wolf C, Kolberg HC, Brucker C, Janni W, Dall P, Schneeweiss A, Marme F, Sutterlin MW, Ruebner M, Theuser AK, Hofmann NM, Bohm S, Almstedt K, Kellner S, Gass P, Luck HJ, Hein A, Schmatloch S, Kalder M, Uleer C, Juhasz-Boss I, Hanf V, Jackisch C, Muller V, Rack B, Belleville E, Wallwiener D, Rody A, Rauh C, Bayer CM, Uhrig S, Huebner H, Goossens C, Brucker SY, Hack CC, Fehm TN, Fasching PA. Invasive disease-free and overall survival after (neo)adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive, HER2-negative early breast cancer treated with upfront letrozole: Experiences from the phase IV PreFace trial. Int J Cancer. 2025 Dec 1;157(11):2363-2373. doi: 10.1002/ijc.70037. Epub 2025 Jul 11.
PubMed 40641449
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01908556
- Acronym / sponsor ID
- PreFace / TRAFO-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,545 participants (actual)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- Novartis, ClinSol
- Study start
- Feb 2009
- Primary completion
- Dec 2015 (estimated)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozol | Experimental | Drug: LetrozoleAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole | Drug | Letrozol |
Primary outcome
Disease free survival in association with tested genotypes (whole genome scan)
Time frame: 5 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Derived from this study: PubMed 40641449Beierlein M, Haberle L, Nabieva N, Maass N, Aktas B, Kummel S, Thomssen C, Wolf C, Kolberg HC, Brucker C, Janni W, Dall P, Schneeweiss A, Marme F, Sutterlin MW, Ruebner M, Theuser AK, Hofmann NM, Bohm S, Almstedt K, Kellner S, Gass P, Luck HJ, Hein A, Schmatloch S, Kalder M, Uleer C, Juhasz-Boss I, Hanf V, Jackisch C, Muller V, Rack B, Belleville E, Wallwiener D, Rody A, Rauh C, Bayer CM, Uhrig S, Huebner H, Goossens C, Brucker SY, Hack CC, Fehm TN, Fasching PA. Invasive disease-free and overall survival after (neo)adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive, HER2-negative early breast cancer treated with upfront letrozole: Experiences from the phase IV PreFace trial. Int J Cancer. 2025 Dec 1;157(11):2363-2373. doi: 10.1002/ijc.70037. Epub 2025 Jul 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole in people with is to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients., run by Institut fuer Frauengesundheit at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival in association with tested genotypes (whole genome scan) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.