A phase II neoadjuvant trial of sequential weekly nab-paclitaxel(nanoparticle albumin-bound paclitaxel) (abraxane) in HER2-negative patients, followed by 5-fluorouracil/ epirubicine/ cyclophosphamide (FEC) in operable breast cancer

A phase II neoadjuvant trial of sequential weekly nab-paclitaxel(nanoparticle albumin-bound paclitaxel) (abraxane) in HER2-negative patients, followed by 5-fluorouracil/ epirubicine/ cyclophosphamide (FEC) in operable breast cancer - neo-WABI BC

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017033

Enrollment

Registered

2015-04-03

Start date

2013-11-15

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

neoadjyuvant sequential weekly nab-paclitaxel in HER2-negative patients, followed by 5-Fluorouracil/ epirubicine/ cyclophosphamide (FEC) weekly nab-paclitaxel 100mg/mm2 4cycle FEC 4cycle 5-Fluorour

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed invasive breast cancer 2) operable primary breast cancer (cT1c-3N0M0/cT1-3N1M0) 3)Evaluated ER and PgR status by IHC 4)Evaluated HER2(-) by IHC/ FISH 5)Age > 20 years 6)evaluable lesion 7)Adequate major organ function (1)WBC >3,000/mm3, Neu> 1,500/mm3 (2)Plt> 100,000/mm3 (3)Hb> 9.0 g/dL (4)AST/ALT < ULT 2.5 (5)Bil < ULT 1.5 (6)Cr< ULT 1.5 (7)ECG< ULT 8)Performance Status (ECOG) 0 or 1 9)Signed written informed consent

Exclusion criteria

Exclusion criteria: 1)History of drug-hypersensitivity. 2) Evaluated HER2(+) by IHC/FISH. 3) Active double cancer. 4)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS) 5) Male patient. 6) Infection or suspected infection. 7) Abnormal ECG or serious cardiac disorder. (1)History of congestive cardiac failure.(NYHA class III/IV)) 8) Complication needed hospitalization. 9) Mental disease with difficulty of taking part in this study. 10) Administration of steroid. 11) HBV related marker (+). 12)Gastrointestinal bleeding. 13)Current pregnancy and lactation, or possibility of pregnancy. 14)Ineligible based on decision of an investigator.

Design outcomes

Primary

Measure	Time frame
pathological Complete Response (pCR)	—

Secondary

Measure	Time frame
Response Rate (RR) Safety	—

Countries

Japan

Contacts

Public ContactEiichiro Noguchi

Tokyo Women's Medical University Department of Surgery II

ein2002@surg2.twmu.ac.jp03-3353-8111

Outcome results

None listed

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