Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)

Inclusion Criteria

• •1. Written informed consent prior to beginning of trial specific procedures.
• •2. Subject must be female and aged ≥ 18 years on day of signing informed consent.
• •3. ECOG 0-1.
• •4. Histologically confirmed, early HER2 positive breast cancer determined by core biopsy of breast tumor lesion.
• •5. Measurable tumor lesion with a size of ≥ 1 cm assessed by sonography or magnetic resonance imaging (MRI) within ≤ 28 days prior to entry. In case of inflammatory disease, the extent of inflammation will be measured.
• •6. Indication for chemotherapy.
• •8. Complete staging within 8 weeks prior to entry with no evidence of distant disease, including bilateral mammography, breast ultrasound, chest-X-ray (or chest CT-scan), liver ultrasound (or liver CT-scan or liver MRI) and bone scan.
• •9. Subjects must provide a core biopsy from tumor lesion before first chemotherapy, after 3 cycles of chemotherapy and after last neoadjuvant study treatment for biomarker analyses.
• •10. Adequate organ function defined as: Absolute neutrophile count ≥1500/µL, Platelets ≥100 000/µL, Hemoglobin ≥10.0 g/dL or ≥6.2 mmol/L, Creatinine ≤1.5 × ULN OR measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN (GFR can also be used in place of creatinine or CrCl), Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases), International normalized ratio (INR) OR prothrombin time (PT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants, LVEF \> 50 %
• •11. Female subjects of childbearing potential must have a negative urine pregnancy test within 72 h prior to study entry and be willing to use an adequate method of contraception for course of the study through 7 months after the last dose of trial treatment.