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Efficacy and Safety of Letrozole vs. Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase III, Phase II
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Treatment
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Active
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Postmenopausal
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Pharmaceutical / Industry
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CZOL446GDE19
NCT00375752
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Trial Description
Summary This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer Eligibility Criteria Inclusion criteria - Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive
- Clinical Stage T1c (Size ≥ 1.5 cm), T2, T3, T4a, b, c, N0 or N1, M0 (TNM Classification). According to the modified RECIST criteria, tumors of size ≥ 1.5 cm are considered measurable by mammography and can be determined as target lesions).
- Tumor measurable by mammography, sonography and clinical examination.
- Adequate bone marrow, renal and hepatic function
- Good health status (ECOG Performance status of 0, 1 or 2)
Exclusion criteria - Prior treatment with letrozole or bisphosphonates. Prior and concomitant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers (BRM's), endocrine therapy other than letrozole (including steroids), and radiotherapy. Patients who have received hormone replacement therapy (HRT) will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.
- 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.
- Evidence of inflammatory breast cancer or distant metastasis.
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
- History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry
Other protocol-defined inclusion/exclusion criteria may apply
Trial Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation | Novartis | | Study Chair |
| Novartis | | Ph: 41 61 324 1111 |
Trial Sites
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| Germany |
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Bad Saarow |
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Berlin |
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Brandenburg an der Havel |
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Cottbus |
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Ebersberg |
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Elmshorn |
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Erlangen |
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Essen |
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Esslingen |
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Essn-Ruttenscheid |
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Freiburg |
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Furth |
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Gifhorn |
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Gorlitz |
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Gottingen |
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Halle |
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Hameln |
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Hannover |
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Heilbronn |
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Herne |
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Homburg/Saar |
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Ingolstadt |
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Kempten |
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Koln |
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Landsberg a. Lech |
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Leipzig |
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Lubeck |
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Mainz |
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Marburg |
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Marktredwitz |
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Maven |
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Munchen |
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Mutlangen |
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Neunkirchen |
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Offenburg |
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Rheinfelden |
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Rosenheim |
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Saarbrucken |
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Stuttgart |
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Ulm |
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Wiesbaden |
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Wolfsburg |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00375752
Information obtained from ClinicalTrials.gov on June 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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