Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. (ARNO-95)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Tamoxifen; Drug: Anastrozole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00287534

1033GR/0001

ARNO-95

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer

Enrollment: 1,059 estimated patients

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent,
• Post-menopausal women ≤75 years,
• histologically confirmed invasive breast carcinoma (no distant metastases),
• positive hormone receptor status,
• continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery

Exclusion criteria

• menopause status maintained by medication,
• pre-operative chemotherapy or hormone therapy or radiation therapy,
• relapse or second carcinoma or previous cancerous disease,
• breast carcinoma in situ,
• simultaneous carcinoma of the opposite side or secondary breast,
• 10 or more tumour-infiltrated lymph nodes.
• serious accompanying diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,059 participants in 2 patient groups

1

Experimental group

Description:

Anastrozole

Treatment:

Drug: Anastrozole

2

Active Comparator group

Description:

Tamoxifen

Treatment:

Drug: Tamoxifen