HER2 Positive Early Breast Cancer MedDRA version: 18.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ABP 980
Product Code: ABP 980
Pharmaceutical Form: Powder for concentrate for solution for infusion
Current Sponsor code: ABP 980
Other descriptive name: biosimilar product to trastuzuma
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Females = 18 years of age Histologically confirmed invasive breast cancer Planning for surgical resection of breast tumor and sentinel node (SN) or axillary lymph node resection Planning neoadjuvant chemotherapy HER2 positive disease defined as: 3+ overexpression by immunohistochemistry (IHC) or HER2 amplification by fluorescence in situ hybridization (FISH) 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 Known ER and PR hormone receptor status at study entry Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Left ventricular ejection fraction (LVEF) of = 55% by 2D echocardiogram Normal bone marrow function as defined by: absolute neutrophil count (ANC) > 1.5 x 10^9 g/dL (1,500/µL); platelets > 100 x 10^9 g/dL (100,000/µL); hemoglobin > 10.0 g/dL. Normal hepatic function as defined by: total bilirubin within normal institutional limits; aspartate aminotransferase (AST) and alanine aminotransferase (ALT); =65 years) yes F.1.3.1 Number of subjects for this age range 111
Exclusion criteria
Exclusion criteria: Bilateral breast cancer Presence of known metastases Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer 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 Pre-existing clinically significant (= grade 2) peripheral neuropathy 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 Severe dyspnea at rest requiring supplementary oxygen therapy History of positivity for hepatitis B surface antigen, hepatitis C virus, or HIV Recent infection requiring a course of systemic anti-infectives that were completed = 14 days before enrollment (with the exception of uncomplicated urinary tract infection) Woman of childbearing potential who is pregnant or is breast feeding Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception)during treatment and for at least 7 months after the last administration of the protocol specified treatment Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study Other investigational procedures while participating in this study are excluded Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients Subject previously has enrolled and/or has been randomized in this study Subject likely to not be available to complete all protocol required study visits or procedures History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the treatment effect of ABP 980 with trastuzumab on pathologic complete response (pCR) in women with early breast cancer ;Secondary Objective: To assess the safety, tolerability, and immunogenicity of ABP 980 compared with trastuzumab ;Primary end point(s): Co-Primary Efficacy Criteria: Risk difference (RD) of the incidence of pathologic complete response (pCR) in breast tissue and axillary lymph nodes Risk ratio (RR) of the incidence of pathologic complete response (pCR) in breast tissue and axillary lymph nodes;Timepoint(s) of evaluation of this end point: Visit 10 (Initiation of investigational product adjuvant therapy cycle 1): Subjects will undergo a lumpectomy or mastectomy with sentinel node or axillary node dissection. Surgery is expected to be scheduled within 3 to 7 weeks after the last dose of investigational product in the neoadjuvant phase and pCR will be analyzed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Risk difference (RD) of pCR in breast tissue Risk ratio (RR) of pCR in breast tissue Risk difference (RD) of pCR in breast tissue and axillary lymph nodes and absence of Ductal Carcinoma in Situ (DCIS) Risk ratio (RR) of pCR in breast tissue and axillary lymph nodes and absence of Ductal Carcinoma in Situ (DCIS) ;Timepoint(s) of evaluation of this end point: Visit 10 (Initiation of investigational product adjuvant therapy cycle 1): Subjects will undergo a lumpectomy or mastectomy with SN or axillary node dissection. Surgery is expected to be scheduled within 3 to 7 weeks after the last dose of investigational product in the neoadjuvant phase Pathology of tumor sample and pCR will then be analyzed. | — |
Countries
Belarus, Brazil, Bulgaria, Canada, Chile, Czech Republic, Germany, Greece, Hungary, Italy, Mexico, Peru, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom
Contacts
Public ContactIHQ Medical Info-Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed