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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Tamoxifen; Drug: Anastrozole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00286117

ITA

1033IT/0002

Details and patient eligibility

About

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.

Enrollment: 448 patients

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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448 participants in 2 patient groups

1

Experimental group

Description:

Anastrozole

Treatment:

Drug: Anastrozole

2

Active Comparator group

Description:

Tamoxifen

Treatment:

Drug: Tamoxifen