Gene Expression Assays and 68 Ga-Affibody HER-2 Imaging PET in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Chinese Patients With HER2 Positive Breast Cancer
This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.
• Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
• Primary tumor greater than (\>) 2 cm in diameter.
• Age ≥ 18 years and \< 70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1.
• Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55%
• Availability of tumor tissue specimen after surgery.
• Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay.
• Histologically proven diagnosis of breast cancer.
• Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
⁃ Had hormonal receptors (ER and PgR) assessed.
⁃ Signed informed consent.
⁃ Able to comply with the protocol.