Randomized phase II study with six cycles of Docetaxel/cyclophosphamide (TC) and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC100) followed by docetaxel for treating hormone receptor-negative breast cancers

Randomized phase II study with six cycles of Docetaxel/cyclophosphamide (TC) and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC100) followed by docetaxel for treating hormone receptor-negative breast cancers - Randomized phase II study with TC and FEC-DOC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002215

Enrollment

100

Registered

2009-07-17

Start date

2009-02-01

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

FEC-DOC Group: 5-FU 500mg/m2 iv day1 Epirubicin 100mg/ m2/day 1 Cyclophosphamide 500mg/m2 iv day1 Every 21 days for 3 cycles, then Docetaxel 100 mg/m2 iv day1 Every 21 days for 3 cycles After

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Invasive breast cancer proven histologically 2) Hormone receptor-negative and without distant metastasis 3)No history of surgery, radiotherapy, hormonal therapy against breast cancer 4)ECOG Performance Status(P.S.) 0-2 5)measurable lesion 6)Sufficient organ function (e.g. bone marrow, cardiac, liver and renal) laboratory parameters WBC >=4,000, <12,000/mm3 or Neutrophil >=2,000 Platelet >=100,000/mm3 Hemoglobin >=9.5g/dl AST and ALT <=1.5x upper limit of normal Total bilirubin <=1.25x upper limit of normal Serum creatinine <=1.5x upper limit of normal 7)Age >=20 to <80 years 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)A history of hypersensitivity reaction to any drugs. 2)seriously compromised 3)Suspected of infection with fever 4)peripheral neuropathy 5)Treatment required pleural or pericardial effusions 6)complication of the active other malignancies 7)Inflammatory breast cancer 8)Male 9)Pregnant or lactation women, or women with suspected pregnancy 10)edema 11)Symptomatic varicella 12) Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 13) Patients who are required concurrent treatment by corticosteroids except for premedication 14)psychological disorders 15) Patients judged by the investigator to be unfit to be enrolled into the study

Design outcomes

Primary

Measure	Time frame
histological effect	—

Secondary

Measure	Time frame
Safety Breast conservation rate Recurrence-free survival Overall survival	—

Countries

Japan

Contacts

Public ContactTakashi Ishikawa

Yokohama City University Medical Center Breast and thyroid surgery

tishik@urahp.yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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