Metastatic Breast CancerPhase 4NCT00241046
Letrozole in the Treatment of 1st and 2nd Line Hormone Receptor Positive Breast Cancer: Pre-therapeutic Risk Assessment
A Phase 4 study testing Letrozole in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals.
Trial summary
The course of the disease in female patients with metastatic mammary carcinoma can vary greatly. In this connection, the individual prognosis depends on a complex interaction of tumor- and patient-related factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Letrozole
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Mar 2005
- 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
- Patients can only take part in the study if they meet all of the following criteria:
- Histologically established mammary carcinoma
- Estrogen receptor (ER+) positive and/or progesterone receptor (PgR+) positive or ER/PgR unknown
- Postmenopausal women; defined by (at least one criterion applicable):
- Amenorrhea ≥ 5 years
- Age ≥ 60
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- Age ≥ 45 with amenorrhea ≥ 12 months
- Postmenopausal LH / FSH values (according to the respective institution)
- Bilateral oophorectomy
- Patients with a primary or recurrent local advanced mammary carcinoma which cannot be curatively treated with surgical procedures or radiation therapy, or patients with a metastatic mammary carcinoma after antiestrogen pretreatment.
- Patients with a recurrence under adjuvant antiestrogen therapy (e.g. tamoxifen; with or without adjuvant chemotherapy) which was administered for at least 6 months or a recurrence within the last 12 months after adjuvant antiestrogen therapy (e.g. tamoxifen, with or without adjuvant chemotherapy) which was administered for at least 6 months or progression under palliative first-line antiestrogen therapy can be included.
- At most, a previous palliative cytostatic treatment is possible
- Measurable or assessable metastases in at least one organ system with objective proof of progression; that is, evidence of newly occurring lesions or an increase in size of preexisting lesions by more than 25% with measurable metastases or worsening with assessable changes within the last 3 months before inclusion in the study
- In the case of bone metastases, imaging methods should verify that at least one preexisting osteolysis or the lytic part of an assessable mixed lesion has increased in size, or that new measurable or assessable bone metastases have developed. In assessable mixed lesions, the measurable part must constitute at least 50% of the size of the metastasis.
- If no previous images are available, the increase in bone pain in connection with the detectable, measurable osteolyses or assessable mixed metastases in the pretreatment image are regarded as progression.
- Previous radiotherapy is permitted as long as the irradiated area is not the only measurable lesion
- Estimated life expectancy of at least 12 weeks
- Performance status of 50 or higher on the Karnofsky scale or WHO grade 0-2.
- Age ≥18 years
- Written informed consent of the patient
Who cannot join
- Patients are not allowed to take part in the study if they meet at least one of the following criteria:
- Cerebral metastasis
- Lymphangitis carcinomatosa of the lung (> 50% of the lung affected)
- Very extensive liver metastasis (in ultrasound or CT > 33% of the liver replaced by metastases)
- Inflammatory mammary carcinoma
- Other primary malignant diseases (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
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- Patients with concomitant serious, unstable cardiac diseases (angina pectoris, arrhythmia, myocardial infarction within the last six months) or uncontrolled diabetes mellitus
- Known hypersensitivity to components of the study medication
- Exclusively osteoblastic or mixed bone metastases, with a lytic percentage < 50%, in so far as no other measurable or assessable lesions are present
- Antihormonal pretreatment with aromatase inhibitors, megestrol acetate, medroxyprogesterone, or GnRH analogues
- Treatment with a hormone replacement therapy
- Taking of non-approved substances within the past 30 days and concomitant treatment with non-approved drugs
- Patients with the following pretreatments should not be included in the study (selection):
- Previous endocrine treatment of a metastatic mammary carcinoma
- Patients with adjuvant or neoadjuvant endocrine treatment with or without chemotherapy within the past 12 months
- Patients with adjuvant or neo-adjuvant endocrine antiestrogen treatment for whom a recurrence occurred during or within 12 months after the end of treatment
- Patients who received more than one regimen of a systemic chemotherapy against their advanced breast cancer
- Other protocol-related inclusion / exclusion criteria may apply
About this study
The course of the disease in female patients with metastatic mammary carcinoma can vary greatly. In this connection, the individual prognosis depends on a complex interaction of tumor- and patient-related factors. To take account of such differences, it is necessary to employ individual methods of treatment which are suited to the course of each patient's disease. Prof. Possinger and Dr. Schmid (Charite Berlin) and Prof. Wischnewsky (University of Bremen) have developed an approach that can help to achieve this goal with the aid of computerized machine learning techniques (MLT).
The use of machine learning methods can be beneficial in oncology in two respects. On the one hand, an attempt can be made to individually estimate clinically relevant parameters like, for example, the recurrence probability or expected survival time as precisely as possible based on the established prognostic factors. And on the other hand, it may be possible with the aid of MLT to understand structural relationships between the clinical result and measured or established tumor-/patient-related variables.
Read more
To analyze the possible benefits of machine learning techniques for patients with metastatic breast cancer, the aim of study FEM-D-2 is to investigate whether it is possible to characterize those patients who either do or do not respond to a specific treatment with a precision of 90%, prospectively estimate the time until worsening of the disease under a given treatment, and classify patients in groups with favorable and poor chances of medium-term survival.
The use of inductive learning algorithms with machine learning also makes it possible to very accurately estimate the time until progression of the tumor growth. In patients who respond to letrozole therapy, the time until tumor progression depends on factors like pain, age, body mass index, disease-free interval, main localization of metastatic spread, and response to previous estrogen therapy. Only very minimal differences are found when comparing the actual time until progression of the disease and that calculated by the system (at least for survival times < 1 year). Furthermore, using machine learning techniques it has become possible to use initial data assessed before a letrozole treatment to estimate the survival time and distinguish patients with a high risk of dying soon from other patients with a more favorable prognosis.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Letrozole
- Keywords
- Breast cancer, Machine learning techniques, Aromatase inhibitors, 1st line treatment, 2nd line treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the the individual pretherapeutic predictions from the computer or doctor with the patient data obtained in a first- or second-line treatment of metastatic breast cancer after progression of the disease
Secondary outcomes (1)
Determination of the individual response at 3 monthly assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startApr 2002
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241046
- Sponsor's protocol ID
- CFEM345ADE02
- Status last verified
- Apr 2012
- First submitted
- 14 Oct 2005
- Last updated
- 19 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole in the Treatment of 1st and 2nd Line Hormone Receptor Positive Breast Cancer: Pre-therapeutic Risk Assessment
- ClinicalTrials.gov ID
- NCT00241046
- Acronym / sponsor ID
- CFEM345ADE02
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast cancer, Machine learning techniques, Aromatase inhibitors, 1st line treatment, 2nd line treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Mar 2005 (actual)
- First posted
- 18 Oct 2005 (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.
The course of the disease in female patients with metastatic mammary carcinoma can vary greatly. In this connection, the individual prognosis depends on a complex interaction of tumor- and patient-related factors. To take account of such differences, it is necessary to employ individual methods of treatment which are suited to the course of each patient's disease. Prof. Possinger and Dr. Schmid (Charite Berlin) and Prof. Wischnewsky (University of Bremen) have developed an approach that can help to achieve this goal with the aid of computerized machine learning techniques (MLT).
The use of machine learning methods can be beneficial in oncology in two respects. On the one hand, an attempt can be made to individually estimate clinically relevant parameters like, for example, the recurrence probability or expected survival time as precisely as possible based on the established prognostic factors. And on the other hand, it may be possible with the aid of MLT to understand structural relationships between the clinical result and measured or established tumor-/patient-related variables.
To analyze the possible benefits of machine learning techniques for patients with metastatic breast cancer, the aim of study FEM-D-2 is to investigate whether it is possible to characterize those patients who either do or do not respond to a specific treatment with a precision of 90%, prospectively estimate the time until worsening of the disease under a given treatment, and classify patients in groups with favorable and poor chances of medium-term survival.
The use of inductive learning algorithms with machine learning also makes it possible to very accurately estimate the time until progression of the tumor growth. In patients who respond to letrozole therapy, the time until tumor progression depends on factors like pain, age, body mass index, disease-free interval, main localization of metastatic spread, and response to previous estrogen therapy. Only very minimal differences are found when comparing the actual time until progression of the disease and that calculated by the system (at least for survival times < 1 year). Furthermore, using machine learning techniques it has become possible to use initial data assessed before a letrozole treatment to estimate the survival time and distinguish patients with a high risk of dying soon from other patients with a more favorable prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically established mammary carcinoma
- Estrogen receptor (ER+) positive and/or progesterone receptor (PgR+) positive or ER/PgR unknown
- Postmenopausal women; defined by (at least one criterion applicable):
- Amenorrhea ≥ 5 years
- Age ≥ 60
Key exclusion criteria (18 listed)
- Patients are not allowed to take part in the study if they meet at least one of the following criteria:
- Cerebral metastasis
- Lymphangitis carcinomatosa of the lung (> 50% of the lung affected)
- Very extensive liver metastasis (in ultrasound or CT > 33% of the liver replaced by metastases)
- Inflammatory mammary carcinoma
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 | – |
Primary outcome
Comparison of the the individual pretherapeutic predictions from the computer or doctor with the patient data obtained in a first- or second-line treatment of metastatic breast cancer after progression of the disease
1 secondary outcome
Determination of the individual response at 3 monthly assessments
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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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.
Novartis study chair
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals.
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 20 inclusion and 18 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: stopped early, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early. 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?
Comparison of the the individual pretherapeutic predictions from the computer or doctor with the patient data obtained in a first- or second-line treatment of metastatic breast cancer after progression of the disease. 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 19 Apr 2012.