None listed
Conditions
Interventions
Adjuvant Therapy: Following surgery, subjects will receive investigational product (ABP980 or trastuzumab) at a dose of 6mg/kg IV infusion Q3W for up to 1 year from the first day of investigational pr
Sponsors
AMGEN INC.,
Eligibility
Sex/Gender
Female
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 8.3.1 Inclusion Criteria Subjects MUST satisfy all of the following entry criteria before they will be allowed to participate in the study: 1. Females ≥ 18 years old 2. Histologically confirmed invasive breast cancer 3. Planning for surgical resection of breast tumor and SN or axillary lymph node resection 4. Planning neoadjuvant chemotherapy 5. HER2 positive disease defined as: o +3 overexpression by immunohistochemistry (IHC) or o HER2 amplification by fluorescence in situ hybridization (FISH) 6. Measurable disease ( assessment method used in order of priority: ultrasound, mammography, MRI, or physical examination) in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm 7. Known ER and PR hormone receptor status at study entry 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9. Left ventricular ejection fraction (LVEF) of ≥ 55 % by 2D echocardiogram (Others, please see Study Protocol)
Exclusion criteria
Exclusion criteria: 8.3.2 Exclusion Criteria If any of the following apply, the subject MUST NOT enter the study: 1. Bilateral breast cancer 2. Presence of know metastases 3. Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer 4. Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix 5. Pre-existing clinically significant (≥ grado 2) peripheral neuropathy 6. Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG) or current poorly controlled hypertension 7. Severe dyspnea at rest requiring supplementary oxygen therapy (Others, please see Study Protocol)
Countries
Belarus, Brazil, Bulgaria, Canada, Czech Republic, Germany, Greece, Hungary, Italy, Mexico, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United Kindgdom
Contacts
Public ContactRocio Cecilia Limas
PHARMACEUTICAL RESEARCH ASSOCIATES PERU SAC
Outcome results
None listed