Spots Global Cancer Trial Database for Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
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Trial Identification
Brief Title: Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
Official Title: An Open Phase III Trial With Letrozole Alone or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
Study ID: NCT00332709
Study Description
Brief Summary: This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an infusion. This trial did not recruit patients in the United States.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Deggendorf, , Germany
Novartis Investigative Site, Frankfurt/Main, , Germany
Novartis Investigative Site, Freiburg, , Germany
Novartis Investigative Site, Georgsmarienhutte, , Germany
Novartis Investigative Site, Gottingen, , Germany
Novartis Investigative Site, Halle, , Germany
Novaertis Investigative Site, Hamein, , Germany
Novartis Investigative Site, Hannover, , Germany
Novartis Investigative Site, Hoxter, , Germany
Novartis Investigative Site, Ilsede, , Germany
Novartis Investigative Site, Jena, , Germany
Novartis Investigative Site, Karlsruhe, , Germany
Novartis Investigative Site, Koln, , Germany
Novartis Investigative Site, Leer, , Germany
Novartis Investigative Site, Lubeck, , Germany
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Munster, , Germany
Novartis Investigative Site, Rostock, , Germany
Novartis Investigative Site, Salzgitter, , Germany
Novartis Investigative Site, Schwenningen, , Germany
Novartis Investigative Site, Stendal, , Germany
Novartis Investigative Site, Volklingen, , Germany
Novartis Investigative Site, Witten, , Germany
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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