PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer

PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer - PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008465

Enrollment

Registered

2012-07-18

Start date

2012-06-01

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

HER2 positive resectable primary breast cancer

Interventions

Administrate 4 cycles of FEC after 4 cycles of nab Paclitaxel and Trastuzumab. Operation is to be performed after chemotherapy. nab Paclitaxel and Trastuzumab 4 cycles nab Paclitaxel 260mg/m2 iv da

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically invasive breast cancer 2. Stage I-IIIA (T1c-3, N0-2a,M0) 3. An age of 20 years to 70 years 4. Hormonal receptor status is confirmed. 5. HER2 status, is confirmed. 1)IHC 3+ 2) FISH score>2.2 6. PS 0-1 7. Measurable lesion according to RECIST standard 8. No prior treatment for breast cancer 9. LVEF more than 55% 10. Adequate EKG 11. Required baseline laboratory data WBC > 4,000/mm3 Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST < ULNx2.5 ALT< ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl 12. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Current history of malignant neoplasm. 2. Bilateral invasive breast cancer. 3. Cases who does not wish to undergo an operation after neoadjuvant chemotherapy. 4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus. 5. Has history of hypersensitivity reaction in important drug of this study. 6. Positive for HBs antigen. 7. 8. With severe peripheral neuropathy. 9. Transfusion within the past 2 weeks. 10. With the history of severe mental disease or under treatment. 11. With active pleural effusion or ascites. 12. Pregnancy, or suspected pregnancy. 13. Cases who physician judged improper to entry this trial.

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
Overall response rate Breast conserving rate Adverse events	—

Countries

Japan

Contacts

Public ContactShinya Tokunaga

Osaka City General Hospital Department of Medical Oncology

s-tokunaga@med.osakacity-hp.or.jp06-6929-1221

Outcome results

None listed

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