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Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.

Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients. - Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006673
Enrollment
20
Registered
2011-11-07
Start date
2011-05-01
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

Docetaxel 75mg/m2 day1, Cyclophosphamide 100mg/m2 day1-14 every 3 weeks, 4 cycles

Sponsors

Shiga University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Histologically deterimined breast cancer 2. Age 20 to 65 years 3. ECOG performance status 0 or 1 4. The patient of possible beginning of the treatment within four weeks after it operates 5. Previous endocrine therapy or chemotherapy for breast cancer 6. Required baseline laboratory parameters WBC >= 3,500/mm3 Neu >= 1,500/mm3 Hb >= 10.0g/dL Plt >= 100,000/mm3 T-Bil <= 1.5mg/dL AST <= 60 IU/L ALT <= 60 IU/L Cre <= 1.5mg/dL normal ECG 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Bilateral breast cancer in same time 2. Active double cancer 3. Inflammatory breast cancer 4. Male breast cancer 5. Severe drug allergic history 6. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infartion within 6 months, liver cirrhosis, uncontrolled diabetes, hemorrhagic tendency) 7. Active infections 8. Peripheral nerve disorders 9. Massive pleural or pericardial effusion 10. Severe edema 11. Interstitial lung disease, pulmonary fibrosis 12. The case which has an underlying disease which needs combined use with steroid 13. Psychiatric disease 14. Pregnant or lactating women 15. Other conditions not suitable for this study 16. Allergy against polysorbert 80

Design outcomes

Primary

MeasureTime frame
Feasibility

Secondary

MeasureTime frame
Safety, Disease-free survival

Countries

Japan

Outcome results

None listed

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