A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer

A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer - A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005100

Enrollment

Registered

2011-02-20

Start date

2010-11-01

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

Breast Cancer

Interventions

4 cycles of S-1/Docetaxel followed by FEC. Docetaxel 40 mg/m2 will be given i.v. on day 1 in combination with S-1 80 mg/m2 orally twice daily on days 1-4 every 21 days. FEC (5-FU 500 mg/m2, Epi-ADM

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed primary breast cancer 2) Clinical stage T1-3 N0-1 M0 3) Age > 20 years and < 80 years 4) No prior surgery, radiation, chemotherapy and endocrine therapy 5) Required baseline laboratory parameters (within 14 days before registration) Hb: more than 9.0 g/dl WBC: more than 4000 /mm3 and less than 12,000 /mm3 Neu: more than 2,000 / mm3 Plt: more than 100,000/mm3 T-Bil: less than 2 times ULM AST: less than 2 times ULN ALT: less than 2 times ULN Cre: less than ULN Ccr: more than 60 ml/min 6) ECOG performance status of 0 - 2

Exclusion criteria

Exclusion criteria: 1) Inflammatory breast cancer and bilateral breast cancer 2) Previous (less than 5 years) or current history of malignant neoplasm 3) Known immediate or delayed hypersensitivity reaction or contraindication to drugs chemically related to any of the study treatment 4) Severe complications (uncontrolled diabetes mellitus, heart failure, interstitial pneumonia or pulmonary fibrosis etc.) 5) Sever bone marrow suppression 6) Renal dysfunction (serum Cre is more than ULN), liver dysfunction ( T-Bil or AST/ALT is more than 2.5 times ULN ) 7) During administration of fluoropyrimidines 8) Active infection (more than 38.0C) 9) During administration of flucytosine, phenytoin, warfarin potassium 10) During administration of pentostatin 11) During pregnancy or lactation 12) Patients judged inappropriate by physicians

Design outcomes

Primary

Measure	Time frame
Primary endpoint is to evaluate the pathological CR rate.	—

Secondary

Measure	Time frame
Secondary endpoint is to evaluate the clinical response rate and relapse- free survival and safety.	—

Countries

Japan

Contacts

Public ContactHiromitsu Jinno

Keio University School of Medicine Department of Surgery

jinno@sc.itc.keio.ac.jp03-3353-1211

Outcome results

None listed

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