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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017034

Enrollment

Registered

2015-04-03

Start date

2013-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

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.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Progression free survival(PFS)	—

Secondary

Measure	Time frame
Response rate(RR) Overall survival(OS) Safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026