Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00287534

Acronym

ARNO-95

Enrollment

1059

Registered

2006-02-07

Start date

1996-11-30

Completion date

2004-09-30

Last updated

2009-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Early Breast Cancer

Brief summary

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

Interventions

DRUGAnastrozole

oral

DRUGTamoxifen

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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 to receive tamoxifen	—

Secondary

Measure	Time frame
To assess difference in overall survival between the two treatment arms	—
To assess difference in disease recurrence between the two treatment arms	—
To assess difference in safety and tolerability between the two treatment arms	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026