Status:
COMPLETED
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Lead Sponsor:
Osaka Medical College
Conditions:
Breast Cancer
HER-2 Positive Breast Cancer
Eligibility:
FEMALE
20-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed ...
Detailed Description
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 Cyclophospha...
Eligibility Criteria
Inclusion
- Histologically confirmed invasive breast cancer
- T1c-3 N0-2a
- Confirmed of hormonal receptor status
- HER2 positive confirmed by IHC 3+ or FISH+
- LVEF \> 50% by echocardiogram or MUGA
- Adequate EKG
- No prior treatment for breast cancer
- PS 0-1
- 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
- Written informed consent
Exclusion
- With history of hypersensitivity reaction for important drug in this study
- With history of invasive breast cancer
- Bilateral invasive breast cancer
- Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
- Positive for HBs antigen and with history of HVB
- With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
- With severe edema
- With severe peripheral neuropathy
- With severe psychiatric disorder
- Pregnant or nursing women
- Cases who physician judged improper to entry this trial
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01432223
Start Date
September 1 2011
End Date
May 1 2014
Last Update
April 22 2015
Active Locations (1)
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1
Osaka Medical College
Takatsuki, Osaka, Japan, 5698686