Randomized Study to Assess the Efficacy of a Further 5 Years of Anastrozole Treatment for Postmenopausal Women with Breast Cancer Completing 5 Years Anastrozole Containing Adjuvant Endocrine Therapy

Randomized Study to Assess the Efficacy of a Further 5 Years of Anastrozole Treatment for Postmenopausal Women with Breast Cancer Completing 5 Years Anastrozole Containing Adjuvant Endocrine Therapy - N-SAS BC 05: Arimidex Extended adjuvant Randomized Study (AERAS)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000818

Enrollment

2500

Registered

2007-09-05

Start date

2007-11-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hormone-responsive postmenopausal primary breast cancer

Interventions

CONTINUE arm: continuation of Anastrozole for 5 years (1 mg/day po QD) STOP arm: no-treatment (no additional medication) for 5 years

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Post operative primary breast cancer proven histologically to be invasive breast cancer. Postmenopause at the randomization. The requirement for menopause is to fulfill at least one of following; a)Age>=55, b)Age>=45 and no menstruation for more than 2 years, c)Bilateral ovariectomy. 2)Patient with no usage ofLH-RHa for adjuvant endocrine therapy, and satisfy one of following; a)taking Anastrozole for 5 years as first line chemotherapy, b)Tamoxifen for 2 to 3 years as 1st line chemotherapy, and followed Anastrozole for 2 to 3 years, namely adjuvant endocrine chemotherapy for 5 years. 3)Clinical stage of T1 to T3, N0 to N2, M0 at the first medical examination(operation). 4)At least one of hormone receptor tests(estrogen receptor, progesterone receptor) is positive. 5)Performance status(ECOG) of 0 to 1. 6)Age at randomization <=80. 7)No relapse and contralateral breast cancer during 6 months before randomization. 8)Sufficient organ functions. The laboratory data during 3 months before randomization fulfill all of the following; a)White blood cell >= 3,000/mm3, b)Platelet count >= 100,000/mm3, c)Hemoglobin >= 9.0g/dl, d)Total bilirubin <=1.5mg/dl, e)GOT, GPT <= 2.5 times of normal upper limit, f)Creatinine <=1.5mg/dl, g)No history of myocardial ischemic disease and congestive heart failure, h)Ischemic heart disease and valvular disorder with no-need for treatment. 9)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Metachronous or synchronous bilateral breast cancer. 2)Invasive carcinoma of other organs(less than 5 years after the last treatment). 3)History of deep venous embolism. 4)History of bone fracture resulted from osteoporosis, and symptom at the randomization. 5)Taking hormone replacement therapy or selective estrogen receptor. 6)Active participant in any other clinical trial. 7)Patients judged inappropriate for this study by the physicians.

Design outcomes

Primary

Measure	Time frame
Disease-Free Survival	—

Secondary

Measure	Time frame
Overall Survival Distant Disease-Free Survival Adverse Events Health Related Quality of Life: HRQOL Cost-Effectiveness (QALY)	—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Research Foundation Comprehensive Support Project for Clinical Research

support@csp.or.jp03-5287-2633

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026