Phase II Study of Primary Chemotherapy with Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients with HER2 Positive Breast Cancer

Phase II Study of Primary Chemotherapy with Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients with HER2 Positive Breast Cancer - Primary Chemotherapy with Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006288

Enrollment

Registered

2011-09-05

Start date

2011-09-01

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

Patients with HER2 positive operable breast cancer

Interventions

Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated. Anthracycline-based regimen (d1, q3w): EC (Epirubicin 90mg/m2 and Cyclophosp

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed invasive breast cancer 2. T1c-3 N0-2a 3. Confirmed of hormonal receptor status 4. HER2 positive confirmed by IHC 3+ or FISH+ 5. LVEF > 50% by echocardiogram or MUGA 6. Adequate EKG 7. No prior treatment for breast cancer 8. PS 0-1 9. Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. With history of hypersensitivity reaction for important drug in this study 2. With history of invasive breast cancer 3. Bilateral invasive breast cancer 4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus 5. Positive for HBs antigen and with history of HVB 6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension 7. With severe edema 8. With severe peripheral neuropathy 9. With severe psychiatric disorder 10. Pregnant or nursing women 11. Cases who physician judged improper to entry this trial

Design outcomes

Primary

Measure	Time frame
To evaluate the pathologic complete response rate	—

Secondary

Measure	Time frame
To evaluate the disease free survival To evaluate the overall response rate To evaluate the histological therapeutic effect To assess breast conserving rate after preoperative chemotherapy To assess the adverse events	—

Countries

Japan

Contacts

Public ContactSatoru Tanaka

Osaka Medical College Hospital Breast and endocrine surgery

sur112@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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