Patients
Cancer
HER2-POSITIVE BREAST CANCER, MAY, CONCOMITANT DISEASE, ONCOLOGY, CANCER
DAP-HER-01 (NCT04293276) was a single-arm, phase 2 clinical trial conducted in the Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital, Zhengzhou, China.The enrollment was conducted between April 9, 2020 and May 19, 2021. Women aged 18–70 years with histologically confirmed advanced HER2-positive breast cancer defined as IHC score of 3 + , or IHC score of 2+ and positive FISH test according to the 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, previously treated with no more than one systemic therapy in advanced setting were eligible for this trial. Further eligibility criteria included at least one measurable lesion based on RECIST 1.1, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, a life expectancy of at least 12 weeks, and adequate organ function. Prior trastuzumab was allowed. Women with childbearing potential must have a negative pregnancy test at screening.Patients were excluded if they had symptomatic BM, or previously received treatment with any TKI targeting HER2 or CDK4/6 inhibitor. Anti-cancer treatment (radiotherapy, chemotherapy, major surgery, or targeted therapy) was not permitted within four weeks before enrollment, except for endocrine therapy, which should be discontinued during the screening period. Patients with concomitant diseases that seriously endanger the safety or affect the completion of the study were excluded, and judged by investigators.