Phase 1 study of TS-1 with Abraxane for metastatic breast cancer

Phase 1 study of TS-1 with Abraxane for metastatic breast cancer - TS-1/ABI Phase 1 study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016377

Enrollment

Registered

2015-01-30

Start date

2012-02-19

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

metastatic breast cancer

Interventions

TS-1:65mg/m2-80mg/m2 day1 through 14 Abraxane:180mg/m2-260mg/m2 day1 Cycles are repeated every 3 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)histologically confirmed breast cancer 2)age more than 20 and below 65 3)PS(ECOG)0-1 4)survival period more than 6 months 5)no effect remain from prior chemotherapy 6)adequate organ function WBC>=4000/mm3 Neu>=2000/mm3 Hb>=9.0g/dL Plt>=100000/mm3 sT-Bil<=1.5mg/dL AST<=100IU/L ALT<=100IU/L Cr>=60ml/min 7)written informed consent

Exclusion criteria

Exclusion criteria: 1)had a previous allergy for TS-1 or Abraxane 2)be pregnant or possible to pregnancy 3)with active breast cancer 4)with severe complications 5)with uncontrolled pleural effusion,ascites and edema 6)with brain metastasis 7)doctor's decision not to be registered to this study

Design outcomes

Primary

Measure	Time frame
To determinate maximum tolerated dose and recommended dose	—

Secondary

Measure	Time frame
Response rate,frequency and degree of side effect	—

Countries

Japan

Contacts

Public Contactkatsuhiko nakatsukasa

kyoto prefectural university of medicine Dept of Endocrine and Breast surgery

kacchan@koto.kpu-m.ac.jp075-251-5534

Outcome results

None listed

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