ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Anastrozole (Drug); Tamoxifen (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Arimidex Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Francesco Boccardo, MD, Principal Investigator, Affiliation: University and National Cancer Research Institute
Summary
The purpose of this study was 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 on tamoxifen.
Clinical Details
Official title: An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary objective of this analysis was 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 on tamoxifen
Secondary outcome: Assess the difference in overall survival/disease recurrence/safety and tolerability between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.
Eligibility
Minimum age: N/A.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Post-menopausal status; age ≤75 years;
- histologically confirmed invasive breast cancer with metastases in the axillary lymph
nodes;
- oestrogen receptor status positive or unknown;
- primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed
Exclusion Criteria:
- Clinical evidence of metastatic disease (including local or remote recurrence, even if
the patient appeared to be in complete remission at the time of randomisation).
Locations and Contacts
Research Site, Chieti, Italy
Research Site, Catania, Italy
Research Site, Ferrara, Italy
Research Site, Genova, Italy
Research Site, Lugo, Italy
Research Site, Messina, Italy
Research Site, Terni, Italy
Research Site, Palermo, Italy
Research Site, Arezzo, Italy
Research Site, Monserrato, Italy
Research Site, Firenze, Italy
Research Site, Forli, Italy
Research Site, Pavia, Italy
Research Site, San Remo, Italy
Research Site, Saronno, Italy
Research Site, Sassari, Italy
Research Site, Torino, Italy
Research Site, Trieste, Italy
Research Site, Roma, Italy
Research Site, Milano, Italy
Research Site, Casalpusterlengo, Italy
Research Site, Pinerolo, Italy
Research Site, Bologna, Italy
Research Site, Vicenza, Italy
Research Site, Rovigo, Italy
Additional Information
AstraZeneca Clinical Study Information
Starting date: March 1998
Ending date: June 2010
Last updated: February 2, 2008
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