Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)

UMIN ID: UMIN000001552

Registered date:05/12/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: postmenopausal breast cancer
• Date of first enrollment: 2008/12/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Letrozole 2.5mg daily p.o. as adjuvant therapy

Outcome(s)

• Primary Outcome: Change rate of FACT-ES score
• Secondary Outcome: Change rate of FACT-G score Arthralgia related with AI FACT-ES score by baseline characters before and after treatment Difference of the evaluation of arthralgia between investigators and patients-self

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1. patients have been treated with medicine which may have some effect for sex hormone or trastuzumab 2. patients being treated with chemotherapy 3. Serious complications ( e.g malignant hypertension, CHF, hepatic failure, MI within 6 months, PE, arrhythmia treatment needed, infection, hemorrhagic tendency ) 4. active multiple cancer

Related Information

• Primary Sponsor: NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)
• Source(s) of Monetary Support: None