Clinical trial NCT00287534: Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
Official title: A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Early Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: German Adjuvant Breast Cancer Group
First posted: 2006-02-07
Enrollment: 1059
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer


Eligibility criteria: Inclusion Criteria:

* Signed informed consent,
* Post-menopausal women ≤75 years,
* histologically confirmed invasive breast carcinoma (no distant metastases),
* positive hormone receptor status,
* continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery

Exclusion Criteria:

* menopause status maintained by medication,
* pre-operative chemotherapy or hormone therapy or radiation therapy,
* relapse or second carcinoma or previous cancerous disease,
* breast carcinoma in situ,
* simultaneous carcinoma of the opposite side or secondary breast,
* 10 or more tumour-infiltrated lymph nodes.
* serious accompanying diseases

Primary outcomes:
measure: To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen
Secondary outcomes:
measure: To assess difference in overall survival between the two treatment arms
measure: To assess difference in disease recurrence between the two treatment arms
measure: To assess difference in safety and tolerability between the two treatment arms
Other outcomes:
Locations:
city: Albstadt
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Cloppenburg
country: Germany
facility: Research Site
city: Eggenfelden
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Goettingen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hanau
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Hoyerswerda
country: Germany
facility: Research Site
city: Idar-Oberstein
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Leonberg
country: Germany
facility: Research Site
city: Lingen
country: Germany
facility: Research Site
city: Luebeck
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Neustadt
country: Germany
facility: Research Site
city: Osnabrueck
country: Germany
facility: Research Site
city: Paderborn
country: Germany
facility: Research Site
city: Pforzheim
country: Germany
facility: Research Site
city: Recklinghausen
country: Germany
facility: Research Site
city: Rosenheim
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Ruesselsheim
country: Germany
facility: Research Site
city: Schleswig
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Titisee-Neustadt
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Waiblingen
country: Germany
facility: Research Site
city: Westerstede
country: Germany
facility: Research Site
city: Worms
country: Germany
facility: Research Site
city: Wuerzburg
country: Germany
facility: Research Site
Study officials:
affiliation: German Adjuvant Breast Cancer Group
name: Manfred Kaufmann, MD
role: PRINCIPAL_INVESTIGATOR
References: