A randomized controlled study comparing Anastrozole+TS-1 as postoperative chemotherapy in ER positive metastatic breast cancer

UMIN ID: UMIN000000795

Registered date:12/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2006/11/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A: Anastrozole (1mg/day) is administratedd orally on days 1-21 until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(+) Breast cancer
Group B: Anastrozole (1mg/day) is administratedd orally on days 1-21 and S-1 (80mg/m2/day) is administrated orally on days 1-21 every 28 days until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(+) Breast cancer
Group C: Anastrozole (1mg/day) is administratedd orally on days 1-21 until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(-) Breast cancer
Group D: Anastrozole (1mg/day) is administratedd orally on days 1-21 and S-1 (80mg/m2/day) is administrated orally on days 1-21 every 28 days until progression or discontimuation of drug (ex. Adverse event et al.)for PgR(-) Breast cancer

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Overall survival (OS), Disease free survival (DFS), Adverse events, Examination of the relevance of 5-FU relative factors (thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP), orotate phosphoribosyl transferase (OPRT) mRNA) and HER2 profile with efficacy, Clinical benefit

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1) concomitant malignancy 2) patient with marked infection 3) patient with marked fever and suspected infection 4) patient with metastasis to CNS 5) complications including ischemic heart disease 6) Active gastrointestinal ulceration 7) Serious Neuropathy 8) Anarmnesis of drug allergy 9) Severe Bone marrow suppression 10) serious renal function disturbance 11) serious liver function disturbance 12) taking other fluoropyrimidine derivatives 13) Under treatment with flucytosine 14) Not suitable for participating in the study for any other reason

Related Information

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