Phase I and dose-finding study of TS-1 with Abraxane for metastatic breast cancer

Phase I and dose-finding study of TS-1 with Abraxane for metastatic breast cancer - TS-1/ABI Phase I tudy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006383

Enrollment

Registered

2011-09-26

Start date

2011-11-01

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

metastatic breast cancer

Interventions

TS-1:65mg/m2-80mg/m2/day day1 through 14 Abraxane:180mg/m2-260mg/m2/day 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 75 3)PS(ECOG)0-1 4)survival period more than 6 months 5)no effect remain from prior chemotherapy 6)adequate organ function WBC>=4,000/mm3 and <=12,000/mm3 NEU>=2,000/mm3 PLT>=100,000/mm3 Hb>=9.0g/dl Cr<=2.0 times of nomal range in institute Ccr>=50ml/min sT-Bil<=1.5mg/dl AST/ALT<=2.0 times of nomal range in institute 7)written informed consent

Exclusion criteria

Exclusion criteria: 1)male breast cancer 2)taboo to use TS-1 or Abraxane 3)had undergone treatment with TS-1 or Abraxane chemotherapy prior to this study 4)pregnant or nursing women or who like be pregnant.possible to pregnancy 5)with active double cancer 6)wiht severe complications 7)uncontrolled dropsy pleural effusion,abdominal dropsy 8)wiht brain metastasis 9)had a previos serious medical illness or allergy 10)doctor's decision not to be registered to this study

Design outcomes

Primary

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

Countries

Japan

Outcome results

None listed

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