AT Versus TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer

Inclusion Criteria

• •Written informed consent for all study specific procedures according to local regulatory requirements prior to beginning specific protocol procedures.
• •Age ≥ 18 years.
• •Male or female patients
• •ECOG performance status ≤1
• •Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies. In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.
• •Centrally confirmed negative HER2-status. Centrally confirmed estrogen and progesterone receptor, and Ki-67 status detected on core biopsy. ER/PR positive is defined as ≥1% stained cells and HER2-positive is defined as IHC 3+ or in-situ hybridisation (ISH) ratio ≥2.0.
• •Provide Formalin-fixed, paraffin-embedded (FFPE) breast tissue to take Homologous Recombinant Deficiency test.
• •Tumor lesion in the breast with a palpable size of \> 2 cm or a sonographical size of \>1 cm in maximum diameter. If the tumor is not detectable with sonography mammography assessment can be considered. The lesion has to be measurable in two dimensions, preferably by sonography. In case of inflammatory disease, the extent of inflammation can be used as measurable lesion.
• •Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to randomization. Results must be above the normal limit of the institution.
• •Laboratory requirements:
• •i. Hematology b) Absolute neutrophil count (ANC) ≥2.0 x 109 / L and c) Platelets ≥100 x 109 / L and d) Hemoglobin ≥10 g/dL (≥ 6.2 mmol/L) Hepatic function e) Total bilirubin ≥1.5x UNL and f) ASAT (SGOT) and ALAT (SGPT) ≥1.5x UNL and g) Alkaline phosphatase ≥2.5x UNL.
• •Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential.
• •Patients must be available and compliant for central diagnostics, treatment and follow-up.
• •Patient must be willing to undergo mandatory research biopsy and blood draw. Prior to biopsy procedures patients must be able to be off medications that could increase the risk of bleeding