oral CEF(Cyclophosphamide, Epirubicin, UFT) adjuvant chemotherapy for breast cancer with intra-patient dose escalation

oral CEF(Cyclophosphamide, Epirubicin, UFT) adjuvant chemotherapy for breast cancer with intra-patient dose escalation - Oral CEF adjuvant chemotherapy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000429

Enrollment

Registered

2006-06-14

Start date

2006-07-01

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

Adjuvant chemotherapy with oral cyclophosphamide and UFT with intra-patient dose escalation (Epirubicin)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Female with pathologically proven primary breast cancer Clinical stage 1,2, 3A(TNM) PS(ECOG) 0~1 Within 12 weeks of breast surgery No prior chemo-endocrine therapy No adjuvant radiotherapy Preserved major organ function Written informed consent

Exclusion criteria

Exclusion criteria: Infection, Fever = or > 38C Serious comorbidity Interstitial pneumonitis/fibrosis Peripheral neuropathy/edema Positive HBsAg Prior use of Anthracycline Decision by primary physician

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD) in oral CEF chemotherapy with intra-patient dose escalation	—

Secondary

Measure	Time frame
Disease free survival time Adverse events graded by CTC	—

Countries

Japan

Contacts

Public ContactHiroshi Ishiguro, MD, PhD

Kyoto University Hospital Outpatient Oncology Unit

hkkishi@kuhp.kyoto-u.ac.jp075-751-4770

Outcome results

None listed

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