3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300508

1033AU/0001

ABCSG 6A

Details and patient eligibility

About

The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.

Sex: Female

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No disease recurrence at time of randomization,
• patients with breast cancer after surgery,
• 5 years (+/- 12 months) of prior endocrine therapy

Exclusion criteria

• Premenopausal patients,
• unknown or negative receptor status,
• Secondary malignant tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)