Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer

Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer - Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017177

Enrollment

Registered

2015-04-20

Start date

2015-03-17

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 Nab-paclitaxel plus S-1 followed by 4 cycles of FEC100 Nab-Paclitaxel plus S-1 Nab-Paclitaxel(100mg/m2) day1,8,15, every 3 weeks S-1(80mg/m2) 2-week administration followed by 1-week

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Cytological confirmed breast cancer 2) Clinical Stage II-IIIA 3) Expected to radical cure by operation and neoadjuvant chemotherapy 4) Has measurable region 5) Age 20 or over 6) No prior surgery, radiation, chemotherapy and endocrine therapy 7) Adequate function of important organs (within 14 days before registaration) 1. WBC: >=3,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T-Bil <= ULN x 2.5 6. AST <= ULN x 1.5 7. ALT <= ULN x 1.5 8. Creatinin <= 1.5mg/dL 8) ECOG performance status 0-1 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity reaction 2) HER2 negative disease 3) Active double cancer 4) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure. 5) Severe mental disorder 6) Sever bone marrow suppression, renal dysfunction, liver dysfunction 7) Has watery diarrhea 8) Active infection or potentiality infection 9) History of hypersensitivity for albumin 10) Grade2 or grater peripheral neuropathy 11)Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 12)Judged ineligible based on physicians' decision

Design outcomes

Primary

Measure	Time frame
pathological complete response rate(ypT0/is ypN0)	—

Secondary

Measure	Time frame
adverse event, quasi pathological complete response rate, response rate, rete of breast conserving surgery, biomarker of chemotherapy, disease free survival	—

Countries

Japan

Contacts

Public ContactHirohito Seki

Kitasato University Kitasato Institute Hospital Breast Center

hirosuke@blue.ocn.ne.jp03-3444-6161

Outcome results

None listed

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