Phase I/II study with GEM/TS-1 combination for metastatic breast cancer (KSCOG BC-03)

Phase I/II study with GEM/TS-1 combination for metastatic breast cancer (KSCOG BC-03) - Phase I/II study with GEM/TS-1 combination for metastatic breast cancer (KSCOG BC-03)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008859

Enrollment

Registered

2012-09-08

Start date

2012-09-01

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

Chemotherapy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.histologically confirmed breast cancer 2.age more than 20 3.PS(ECOG)0-1 4.survival period more than 6 months 5.more than 1 months passed after chemotherapy 6.adequate organ function 1)WBC>=3,000/mm3 and <=12,000/mm3 2)NEU>=2,000/mm3 3)PLT>=100,000/mm3 4)Hb>=9.0g/dl 5)Cr<=1.5 times of normal range in institute 6)Ccr>=60ml/min 7)sT-Bil<=1.5mg/dl 8)AST/ALT<=2.0 times of normal range in institute 9)written informed consent

Exclusion criteria

Exclusion criteria: 1.Non-invasive cancer or micro-invasive cancer 2. taboo to use Gemcitabine or TS-1 3. male breast cancer 4.pregnant or nursing women or who suspected pregnant 5.with active double cancer 6.with severe complications 7.had a previous cardiac dysfunction or having cardiac dysfunction 8.uncontrolled edema 9.had a previous serious medical illness or allergy 10.doctor's decision not to be registered to this study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Countries

Japan

Contacts

Public ContactIwakuma Nobutaka

same as above same as above

Iwakuma@med.kurume-u.ac.jp0942-31-7566

Outcome results

None listed

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