Breast Cancer, Estrogen Receptor Negative Neoplasm, HER-2 Positive Breast Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.
Interventions
DRUGnab-paclitaxel
nab-paclitaxel 260mg/m2 q3w
DRUGTrastuzumab
trastuzumab 6 mg/kg (8 mg/kg as the loading dose)
Sponsors
Osaka Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed invasive breast cancer 2. Tumor size of 3cm or less and N0 3. Hormone receptors have been identified as negative 4. HER2 positive confirmed by IHC 3+ or FISH+ 5. LVEF \> 50% by echocardiogram or MUGA 6. Adequate EKG 7. No prior treatment for breast cancer 8. PS 0-1 9. 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 10. Written informed consent
Exclusion criteria
1. With history of hypersensitivity reaction for important drug in this study 2. With history of invasive breast cancer 3. Bilateral invasive breast cancer 4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus 5. Positive for HBs antigen or HCV antibody 6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension 7. With severe edema 8. With severe peripheral neuropathy 9. With severe psychiatric disorder 10. Pregnant or nursing women 11. The case that is judged to be unsuitable for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | Up to 12 weeks after the protocol therapy |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival | Five years after the last patient enrolled |
| Objective response rate | Up to 6 weeks after the protocol therapy |
| Pathological response rate | Up to 12 weeks after the protocol therapy |
| Breast-conserving surgery rate | Up to 6 weeks after the protocol therapy |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Up to 6 weeks after the protocol therapy |
Countries
Japan
Outcome results
None listed