Antiestrogen vs aromatase inhibitor after chemotherapy for adjuvant setting: Efficacy of endocrine therapy after chemotherapy in postoperative adjuvant therapy for breast cancer

UMIN ID: UMIN000000610

Registered date:01/09/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast cancer patients who have received chemotherapy either before or after surgery are the study subjects
• Date of first enrollment: 2007/05/01
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Fareston (toremifene citrate): 40-mg tablets orally once daily. (For purposes of long-term, no-change evaluation, medication administration will be continued unless definite exacerbation of the clinical condition is observed.)
Arimidex: 1-mg tablets by mouth once daily. (For purposes of long-term, no-change evaluation, medication administration will be continued unless definite exacerbation of the clinical condition is observed.)

Outcome(s)

• Primary Outcome: Recurrence-free rate
• Secondary Outcome: - Survival rate. - Drug adverse events. - Bone metabolism markers (BAP, NTx). - BMD (DXA method): Lumbar vertebrae, femoral neck. - Laboratory values of lipid metabolism (TC, LDL, HDL, Lp(a), TG). - Compliance.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: (1) Pregnant or breast feeding. (2) Bilateral or inflammatory breast cancer. (3) Multiple cancers. (4) Life-threatening metastases. (5) History of serious hypersensitivity. (6) Judged ineligible for the study by the study doctor.

Related Information

• Primary Sponsor: Japan Breast Cancer Research Network
• Source(s) of Monetary Support: None
• Secondary ID(s): NCT00437359