- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01432223
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
Study Overview
Status
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Osaka
-
Takatsuki, Osaka, Japan, 5698686
- Osaka Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nab-paclitaxel
Nab-paclitaxel q3w 260mg/m2
|
Nab-paclitaxel 260mg/m2 q3w
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the pathological complete response rate
Time Frame: 1 year from last patient enrolled
|
1 year from last patient enrolled
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease free survival
Time Frame: 5 years from the last patient enrolled
|
5 years from the last patient enrolled
|
Overall response rate
Time Frame: After the protocol therapy
|
After the protocol therapy
|
Pathological response rate
Time Frame: After the protocol therapy
|
After the protocol therapy
|
Breast-conserving surgery rate
Time Frame: After the protocol therapy
|
After the protocol therapy
|
Safety
Time Frame: Within the protocol thepapy
|
Within the protocol thepapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mitsuhiko Iwamoto, MD, PhD, Osaka Medical College
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMC-BC01
- UMIN000006288 (Registry Identifier: University hospital Medical Information Network)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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