Patient Population
tumor, PBC, neutropenia
TUMOR, HER2-POSITIVE BREAST CANCER, PBC, NEUTROPENIA, MALIGNANCIES, CONGESTIVE HEART FAILURE, CONCOMITANT DISEASE, HER2-NEGATIVE BREAST CANCER
The current study was a planned interim analysis of a phase II study embedded within a larger academically driven prospective open-label phase II and phase III diagnostic trial, approved by the Swedish Medical Products Agency (EudraCT 2017-002115-34; diarienummer, 5.1-2018-30296; Women with newly diagnosed stage II or stage III PBC and planned for neoadjuvant therapy or women with confirmed progression in MBC and planned for HER2-targeted therapy concomitant with chemotherapy were considered as candidates for this study. The inclusion criteria included women with biopsy-confirmed HER2-positive or borderline HER2-positive breast cancer, at least 1 tumor lesion of at least 1.0 cm, at least 1 tumor available for biopsy, a negative pregnancy test and active contraceptive measures for women of child-bearing age, at least 18 y of age, a predicted survival of more than 12 wk, and a World Health Organization performance status of 2 or lower.The exclusion criteria included women with biopsy-confirmed HER2-negative breast cancer before enrollment in this study; other coexisting malignancies; uncontrolled serious concomitant disease including congestive heart failure, inadequate organ function such as neutropenia, or abnormally high liver or kidney function tests (absolute neutrophil count < 1,500 cells/mmPatients fulfilling the above-mentioned criteria underwent [