NIPH Clinical Trials Search

UMIN ID: UMIN000001090

Registered date:20/03/2008

Randomized Phase III Study of Adjuvant Endocrine-Therapy with or without Chemotherapy for Postmenopausal Breast Cancer Patients who Responded to Neoadjuvant Letrozole

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedpostmenopausal primary breast cancer
Date of first enrollment2008/05/16
Target sample size850
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)CL(chemotherapy*-letrozole) : letrozole for 4.5-5.0 years (2.5mg/day po QD) after chemotherapy* . *one of the following regimens: CMF, AC, EC, TC, FAC, FEC, AC-T/EC-T, FEC-T, TAC L (letrozole) : letrozole for 4.5-5.0 years (2.5mg/day po QD)


Primary OutcomeDisease-Free Survival(DFS)
Secondary OutcomeOverall Survival(OS), Clinical response rate for neoadjuvant letrozole, Pathological response, Breast-conserving surgery rate, DFS and OS by the clinical response (CR / PR / SD / PD) of neoadjuvant letrozol, Safety, HRQOL, Cost-Effectiveness(QALY)

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum75years-old
Include criteria
Exclude criteria1. Positive sentinel lymph nodes before the registration. 2. Synchronous or asynchronous bilateral breast cancer. 3. Multifocal breast cancer of plural region 4. Double invasive carcinoma (in less than 5 years after the last treatment). 5. History of breast cancer. 6. Under treatment with continuous systemic steroid, estrogen or SERM. 7. Active participant in any other clinical trial for breast cancer. 8. Patient judged inappropriate for this study by the physicians.

Related Information


public contact
Name Akira Yamao
Address 1-1-7, Nishiwaseda, Shinjyuku-ku, Tokyo, 169-0051JAPAN Japan
Telephone 03-5287-2633
Affiliation Public Health Research Foundation Comprehensive Support Project for Clinical Research
scientific contact
Name Hiroji Iwata
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan Japan
Telephone 052-762-6111
E-mail no@mail
Affiliation Aichi Cancer Center Department of Breast Oncology