Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
20 Years
70 Years
Female
Breast Cancer, HER-2 Positive Breast Cancer, Effects of Chemotherapy
Trial Information
Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
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 Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and
Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and
Cyclophosphamide 500mg/m2)
Nab-paclitaxel 260mg/m2 (d1, q3w)
Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle
over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the pathological complete response rate
Outcome Time Frame:
1 year from last patient enrolled
Safety Issue:
No
Principal Investigator
Mitsuhiko Iwamoto, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Osaka Medical College
Authority:
Japan: Institutional Review Board
Study ID:
OMC-BC01
NCT ID:
NCT01432223
Start Date:
September 2011
Completion Date:
August 2014
Related Keywords:
- Breast Cancer
- HER-2 Positive Breast Cancer
- Effects of Chemotherapy
- Trastuzumab
- Neoadjuvant chemotherapy
- Primary chemotherapy
- Breast Neoplasms
Name | Location |
|---|
