Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB

UMIN ID: UMIN000000881

Registered date:08/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Postmenopausal Breast Cancer
• Date of first enrollment: 2007/07/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Letrozole (2.5 mg Tablet) is internally administered once a day everyday.

Outcome(s)

• Primary Outcome: Clinical tumor response rate
• Secondary Outcome: 1. Percentage of performing breast- conserving surgery 2.Histological effect in the extensive intraductal component of breast cancer 3.Difference in clinical tumor response effect depending on the expression of HER2 4.Effect for suppressing estradiol concentration in cancer tissues 5.Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Female
• Exclude criteria: 1.Under chemotherapy and hormone therapy(for tumors) 2.Invasive carcinoma of other organs(less than 5 years after the last treatment) 3.With past history of breast cancer 4.Synchronous bilateral breast cancer 5.Under treatment with the drugs that may influence on the conditions of sex hormone

Related Information

• Primary Sponsor: Department of Breast and Thyroid Surgery, Kawasaki Medical School
• Secondary Sponsor: none
• Source(s) of Monetary Support: none,none