Clinical trial NCT00286117: ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Institute of Cancer Research, United Kingdom
First posted: 2006-02-03
Enrollment: 448
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 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.


Eligibility 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).

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Casalpusterlengo
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Chieti
country: Italy
facility: Research Site
city: Ferrara
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Forli
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Lugo
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Monserrato
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Pinerolo
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rovigo
country: Italy
facility: Research Site
city: San Remo
country: Italy
facility: Research Site
city: Saronno
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Terni
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Vicenza
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Arimidex Medical Science Director, MD
role: STUDY_DIRECTOR
affiliation: University and National Cancer Research Institute
name: Francesco Boccardo, MD
role: PRINCIPAL_INVESTIGATOR
References: