Clinical trial of the efficacy of new S-1 schedule (administered 14days followed by 7 days rest) for metastatic or recurrent breast cancer

Clinical trial of the efficacy of new S-1 schedule (administered 14days followed by 7 days rest) for metastatic or recurrent breast cancer - KBCOG13

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011258

Enrollment

Registered

2013-09-01

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

brest cancer

Interventions

S-1 depending on BSA and Ccr is administered orally twice daily after morning and evening meals from day1-14,followed by 7 days rest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically comfirmed breast cancer 2)metastatic or recurrent breast cancer 3)with at least one evaluable lesion 4)without chemotherapy after decided metastatic or recurrent cancer 5)over 20 years old 6)EOG perfomance status 0-2 7)without previous 5-FU chemotherapy or with interval period of 6months after pre or post operative 5-FU chemothrapy 8)with interval period of 7days after endocrine therapy,or with interval period of 14days after radiation therapy 9)required baseline laboratory parameters WBC>3000/mm3 neutrophili>1500/mm3 Plt>100,000/mm3 T-Bil<2.0mg/dL AST,ALT<100IU/L Ccr>50mL/min 10)without severe heart problem 11)written informed consent was obtained

Exclusion criteria

Exclusion criteria: 1)HER2 positive 2)allergy for the medicine of the protocol 3)active double cancer 4)brain metastasis which needs treatment or radiation therapy in an emergency 5)severe liver metastasis or Lung metastasis with dyspnea 6)with pleural effusion,ascitis,ericardial effusion which needs treatment in an emergency 7)active infection 8)interstitial pneumonia 9)HBV antigen positive 10)uncontoroled diabetes mellitus 11)mental disease 12)pregnant or nursing women ,women who like to be pregnant 13)with doctors decision for exclusion

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival Time to Treatment failure Response rate	—

Countries

Japan

Contacts

Public ContactMayuko Miki

Hyogo Cancet Center Breast Surgical Oncology

mikimayu@hyogo-cc.jp0789291151

Outcome results

None listed

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