ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

AstraZeneca448 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

448

Conditions

Breast Cancer

Interventions

AnastrozoleDRUG

oral

TamoxifenDRUG

oral

Eligibility

Sex: FEMALEMax age: 75 Years

Medical Language ↔ Plain English

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 (25)

Research Site

Arezzo, Italy

Research Site

Bologna, Italy

Outcomes

Primary Outcomes

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

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.

Data from ClinicalTrials.gov

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