Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)

Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01) - Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000517

Enrollment

Registered

2006-11-09

Start date

2006-11-01

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

Reccurent or metastatic breast cancer

Interventions

Chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Reccurent, metastatic breast cancer Previous anthracycline, taxane Her 2 negative PS 0-2 Adequate organ function Informed consent

Exclusion criteria

Exclusion criteria: Prior chemotherapy with CPT-11, S-1 Diarrhea No lesion other than bone metastasis Brain metastasis Serious cardiac disease

Design outcomes

Primary

Measure	Time frame
Phase I:MTD, DLT, RD Phase II:Clinical response, Clinical efficacy	—

Secondary

Measure	Time frame
Phase II:Adverse events, TTP, OS	—

Countries

Japan

Contacts

Public ContactKatsumasa Kuroi

Japan Breast Cancer Research Group (JBCRG) Head office

office@jbcrg.jp03-6264-8873

Outcome results

None listed

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