Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer (DATA)

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Anastrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT00301457

D5392NL003

EUDRAct No: 2005-006167-31

Details and patient eligibility

About

The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2-3 years tamoxifen

Enrollment: 1,914 patients

Sex: Female

Ages: 45 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• postmenopausal patients with hormone receptor positive breast cancer who have already received 2 to 3 years of adjuvant tamoxifen, and who never had signs of loco-regional recurrences or distant metastasis

Exclusion criteria

• Previous hormonal therapy as adjuvant breast cancer treatment besides tamoxifen.
• Previous history of invasive breast cancer within the last 10 years, other then the breast cancer that is currently treated with tamoxifen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,914 participants in 2 patient groups

1

Experimental group

Description:

6 years adjuvant anastrozole therapy

Treatment:

Drug: Anastrozole

2

Experimental group

Description:

3 years adjuvant anastrozole therapy

Treatment:

Drug: Anastrozole