A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer

A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer - A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer Ryukyu Breast club 002 study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004586

Enrollment

140

Registered

2010-11-19

Start date

2010-10-01

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

Follow up with no treatment until the metastasis or the relapse are confirmed after neo-adjvant chemotherapy or adjvant chemotherapy by standard regimen with evidence UFT (250mg/m2/day) is administere

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Intermediate and high risk for recurrence according to the classification proposed by St.Gallen, 2007 2. Histologically confirmed Breast Cancer . 3. Receive neo-adjvant chemotherapy or adjvant chemotherapy by standerd regimen with evidence. 4. Within 12 weeks after standard regimen chemotherapy. 5. The patient has been confirmed to be HER2 negative. 6. Age >=20 to <70 years 7. ECOG Performance status 0-1 8. Oral intake is possible 9. Sufficient organ function. WBC >=3,500, <12,000/mm3 or Neutrophil >=1,500 Platelet >=100,000/mm3 Hemoglobin >=9.0g/dl Total bilirubin <1.5 mg/dL AST and ALT <100 IU/L Serum creatinine <1.5 mg/dL 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. HER2 positive 2. Severe complications (uncontrolled diabetes mellitus, infection, heart failure which needs medical treatment (unstable angina pectoris, history of myocardial infarction occurred within 6 months), mental disorder) 3. Interstitial lung disease, pulmonary fibrosis 4. History of serious drug allergy 5. Active other malignancies 6. During pregnancy or lactation. 7. Patients judged inappropriate by physicians

Design outcomes

Primary

Measure	Time frame
5-year Disease free survival	—

Secondary

Measure	Time frame
Overall survival, Incidence of adverse events, Feasibility	—

Countries

Japan

Contacts

Public ContactKoichi Kuninaka

University of the Ryukyus Hospital Surgery1

098-895-1163

Outcome results

None listed

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