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

UMIN ID: UMIN000001090

Registered date:20/03/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: postmenopausal primary breast cancer
• Date of first enrollment: 2008/05/16
• Target sample size: 850
• Countries of recruitment: Japan
• Study type: Interventional

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)

Outcome(s)

• Primary Outcome: Disease-Free Survival(DFS)
• Secondary Outcome: Overall 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 minimum: Not applicable
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1. 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

• Primary Sponsor: NEOS executive committee
• Source(s) of Monetary Support: Public Health Research Foundation