A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab for node-positive breast cancer

A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab for node-positive breast cancer - EC-wnabPTX as NAC PII

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007648

Enrollment

Registered

2012-04-02

Start date

2011-04-01

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

In HER2negative cases, EC(E90mg/m2, C600mg/m2 4courses) followed by weekly nab-PTX(125mg/m2 on day1,8,15 in 28days 4courses) as a neoadjuvant therapy. In HER2 posotive cases, EC(E90mg/m2, C600mg/m2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with histologically diagnosed invasive breast cancer Resectable case Category of the T1-4 N1-3 Without previous operation or chemotherapy With measurable lesions ECOG performance status 0-2 Adequate organ function Written informed concent

Exclusion criteria

Exclusion criteria: Severe complications history of hypersensitivity reaction for important drug in this study Bilateral breast cancer Inflammatory breast cancer Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
pathological CR(pCR rate)	—

Secondary

Measure	Time frame
the breast conserving rate, toxicities, feasibility and overall survival	—

Countries

Japan

Contacts

Public ContactAkira Hirano

Tokyo Women&#39;s Medical University, Medical Center East Department of Breast Surgery

ahirasu@dnh.twmu.ac.jp03-3810-1111

Outcome results

None listed

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