Breast CancerNCT01249456
Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients
An observational study of Breast Cancer and Letrozole, run by Novartis Pharmaceuticals at 1 site in South Korea.
Trial summary
Title of study: An observational, multicenter study on the safety and efficacy of Femara® (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed adjuvant Tamoxifen or Toremifen treatment Objectives: The major objective of the study is to assess safety and efficacy of Femara® in women who… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Letrozole
- How many people
- 392 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to Apr 2015
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Postmenopausal early breast cancer patients who have finished adjuvant treatment with Tamoxifen or Toremifen for 5 years after curative surgery as "indications" described in local product labeling
Who may be able to join
- Written informed consent form
- Postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
- Age ≥50 years with cessation of menses and Age <50 years Postmenopausal status defined by one of the following:
- FSH level > 30-40 IU/L
- cessation of menses over the past 1 year
- are/become amenorrheic due to either chemotherapy or LHRH, are/become amenorrheic due to surgical ovarian ablation
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- The tumor was to be ER and/or PgR-positive or the receptor status could have been unknown
- No evidence of recurrence of the disease at entry
- Patient must be accessible for follow-up
Who cannot join
- Those patients known to have had receptor-negative primary tumors
- Any concurrent malignancy
- Patients who previously received hormone replacement therapy (HRT) during 5 years of adjuvant therapy with tamoxifen or toremifen
- Patients who are currently receiving other aromatase inhibitors, or chemotherapy
- Patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
- Life expectancy < 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Multicenter Study on the Safety and Efficacy of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients Who Completed Adjuvant Tamoxifen or Toremifen Treatment
Title of study: An observational, multicenter study on the safety and efficacy of Femara® (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed adjuvant Tamoxifen or Toremifen treatment
Objectives:
Read more
The major objective of the study is to assess safety and efficacy of Femara® in women who had undergone resection of a primary breast cancer and subsequently received prior adjuvant tamoxifen or toremifen therapy for 5 years in real-life condition.
The study aims at the following objectives:
- To identify unknown adverse reactions, especially serious adverse reactions
- To evaluate incidence and descriptions of adverse reactions under the routine drug use
- To identify factors that may affect the safety of Femara®
- To identify factors that may affect the efficacy of Femara®
Methodology: This will be an open-label, multi-center, single-arm, observational phase IV study.
Number of centers \& patients: Approximately 610 (planned No. of patients for total study period) patients from 4 centers will be enrolled in this study.
Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment with Tamoxifen or Toremifen for 5 years after curative surgery as "indications" described in local product labeling.
Investigational drug: Femara® will be administered orally as described in "dose \& administration" of local product labeling up to 3 years.
Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3 years with renewal of contract on yearly basis.
- Conditions
- Breast Cancer, Letrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Femara(Letrozole) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify unknown adverse reactions, especially serious adverse reactions
Measured: for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startMay 2006
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249456
- Sponsor's protocol ID
- CFEM345DKR04
- Status last verified
- Jun 2015
- First submitted
- 25 Nov 2010
- Last updated
- 25 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multicenter Study on the Safety and Efficacy of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients Who Completed Adjuvant Tamoxifen or Toremifen Treatment
- ClinicalTrials.gov ID
- NCT01249456
- Acronym / sponsor ID
- CFEM345DKR04
- Conditions
- Breast Cancer, Letrozole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Nov 2010 (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.
Title of study: An observational, multicenter study on the safety and efficacy of Femara® (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed adjuvant Tamoxifen or Toremifen treatment
Objectives:
The major objective of the study is to assess safety and efficacy of Femara® in women who had undergone resection of a primary breast cancer and subsequently received prior adjuvant tamoxifen or toremifen therapy for 5 years in real-life condition.
The study aims at the following objectives:
- To identify unknown adverse reactions, especially serious adverse reactions
- To evaluate incidence and descriptions of adverse reactions under the routine drug use
- To identify factors that may affect the safety of Femara®
- To identify factors that may affect the efficacy of Femara®
Methodology: This will be an open-label, multi-center, single-arm, observational phase IV study.
Number of centers \& patients: Approximately 610 (planned No. of patients for total study period) patients from 4 centers will be enrolled in this study.
Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment with Tamoxifen or Toremifen for 5 years after curative surgery as "indications" described in local product labeling.
Investigational drug: Femara® will be administered orally as described in "dose \& administration" of local product labeling up to 3 years.
Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3 years with renewal of contract on yearly basis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femara(Letrozole) | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal early breast cancer patients who have finished adjuvant treatment with Tamoxifen or Toremifen for 5 years after curative surgery as "indications" described in local product labeling
Key inclusion criteria (9 listed)
- Written informed consent form
- Postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
- Age ≥50 years with cessation of menses and Age <50 years Postmenopausal status defined by one of the following:
- The tumor was to be ER and/or PgR-positive or the receptor status could have been unknown
- No evidence of recurrence of the disease at entry
Key exclusion criteria (6 listed)
- Those patients known to have had receptor-negative primary tumors
- Any concurrent malignancy
- Patients who previously received hormone replacement therapy (HRT) during 5 years of adjuvant therapy with tamoxifen or toremifen
- Patients who are currently receiving other aromatase inhibitors, or chemotherapy
- Patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify unknown adverse reactions, especially serious adverse reactions
Time frame: for 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
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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?
An observational study of Breast Cancer and Letrozole, run by Novartis Pharmaceuticals at 1 site in South Korea.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jun 2015. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To identify unknown adverse reactions, especially serious adverse reactions (time frame: for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2015.