Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ABP 980; Trastuzumab; Paclitaxel; Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection
Intervention description: ABP 980 was administered at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.; Trastuzumab was administered at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.; Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).
Intervention MeSH terms: Paclitaxel; Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 725.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Epidermal Growth Factor Receptor 2 (HER2); Positive Early Breast Cancer

Summary:

      The purpose of this research study is to compare the effectiveness and safety of ABP 980
      against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive
      early breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females ≥ 18 years of age

          -  Histologically confirmed invasive breast cancer

          -  Planning for surgical resection of breast tumor and sentinel node or axillary lymph
             node resection

          -  Planning neoadjuvant chemotherapy

          -  HER2 positive disease

          -  Measurable disease in the breast after diagnostic biopsy, defined as longest diameter
             ≥ 2.0 cm

          -  Known estrogen receptor (ER) and progesterone receptor (PR) hormone receptor status at
             study entry

          -  Normal bone marrow function

          -  Normal hepatic function

          -  Normal renal function

          -  Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)-approved
             informed consent form before any study specific procedures

        Inclusion Criteria for Randomization:

          -  Left ventricular ejection fraction (LVEF) of ≥55% by 2D echocardiogram

          -  Complete all 4 cycles of run-in chemotherapy

        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 human
             immunodeficiency virus (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