A Phase II trial of alternate-day S-1 for anthracyclin･taxane refractory metastatic breast cancer

UMIN ID: UMIN000017034

Registered date:03/04/2015

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2013/09/01
• Target sample size: 22
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral administration of alternata-day S-1 for metastatic breast cancer.
[Alternate-day S-1]
･Oral S-1 administration is Alternate-day about 80-120mg/day depending on body surface area.

Outcome(s)

• Primary Outcome: Progression free survival(PFS)

Secondary Outcome

Response rate(RR)
Overall survival(OS)
Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female

Include criteria

･Female unresectable metastatic or recurrence breast cancer.
･Histologically confirmed invasive breast cancer.
･At least one evaluable lesion.
･Evaluated ER and PgR status by IHC.
･Evaluated HER2(-) by IHC/FISH.
･Prior treatment of anthracyclin/taxane.
･20 to 75 years old at diagnosis.
･Adequate major organ function.
･WBC>=3,000/mm3 or Neu>=1,500/mm3
･Plt>=100,000 /mm3
･Hb>=9.0 g/dL
･AST/ALT <=ULN*2.5
･Bil<=ULN*1.5
･Cr<=ULN*1.5
･CCr>=60mL/min
･Performance status(ECOG) 0 or 2
･Non life threatening.
･Written informed consent.

Exclude criteria

･History of drug-hypersensitivity.
･Evaluated HER2(+) by IHC/FISH.
･Active double cancer.
･Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
･Male patient.
･Infection or suspected infection.
･Abnormal ECG or serious cardiac disorder.
･History of congestive cardiac failure.(NYHA class III/IV)
･Complication needed hospitalization.
･Administration of flucytosine phenytoin or warfarin potassium.
･Mental disease with difficulty of taking part in this study.
･Administration of steroid.
･HBV related marker (+).
･Gastrointestinal bleeding.
･Current pregnancy and lactation, or possibility of pregnancy.
･Ineligible based on decision of an investigator.

Related Information

Primary Sponsor

Tokyo Women`s Medical University
Department of Surgery II

• Source(s) of Monetary Support: None