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

Not Applicable

• Conditions: HER2 positive resectable primary breast cancer

• Registration Number: JPRN-UMIN000008465
• Lead Sponsor: Osaka Breast Cancer Chemo-Endocrine Therapy Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-18
• Study Completion: 2017-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate

Secondary Outcome Measures

Name	Time	Method
Overall response rate Breast conserving rate Adverse events