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A phase II study of neoadjuvant docetaxel/cyclophosphamide (DC) followed by epirubicin/cyclophosphamide (EC) for triple-negative breast cancer

A phase II study of neoadjuvant docetaxel/cyclophosphamide (DC) followed by epirubicin/cyclophosphamide (EC) for triple-negative breast cancer - DC followed by EC as NAC PII

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011031
Enrollment
34
Registered
2013-06-24
Start date
2013-08-01
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

DC (DTX75mg/m2, CPA600mg/m2 q3w x4courses) followed by EC(EPI90mg/m2, CPA600mg/m2 q3w x4courses)as a neoadjuvant therapy

Sponsors

Tokyo Women's Medical University
Lead Sponsor
Tokyo Women&#39
Collaborator
s Medical University, Yachiyo Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with histologically diagnosed invasive breast cancer Resectable case Category of the T1-4 N1-3 M0 or T2-4N0M0 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

MeasureTime frame
pathological CR(pCR rate)

Secondary

MeasureTime frame
the breast conserving rate, toxicities, ki-67 labeling index, feasibility and overall survival

Countries

Japan

Contacts

Public ContactAkira Hirano

Tokyo Women'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