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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00333047 |
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Date of registration:
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31/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy
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Scientific title:
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A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy |
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Date of first enrolment:
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July 2002 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00333047 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Novartis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis |
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Key inclusion & exclusion criteria
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Inclusion criteria
- Histologically proven metastatic breast cancer
- Measurable disease, patients with bone only disease are not eligible
- Age = 65 years
- Performance status = 2 (World Health Organization)
- Estimated life expectancy under therapy of at least 3 months
- Estrogen-/progesterone-receptor status positive or unknown
- Signed informed consent
Exclusion criteria
- Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with
aromatase inhibitors in the adjuvant setting
- Disease-free interval after adjuvant therapy < 1 year
- Clinical signs of central nervous system metastases
- Renal, bone marrow, or liver insufficiency
- Severe coronary heart disease, cardiac insufficiency or other severe concomitant
internal diseases
- Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion
criteria may apply.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Intervention(s)
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Drug: Letrozole
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Primary Outcome(s)
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Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression
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Secondary Outcome(s)
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Time to progression and safety and toxicity during treatment
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Secondary ID(s)
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CFEM345ADE07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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