Study design and patients
Tumors, Cancer
METASTASIS, DISEASE, METASTATIC DISEASE, TUMORS, ONCOLOGY, CANCER
The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles. The protocol was approved by the ethics committee of Zhejiang Cancer Hospital, Sun Yat-sen University Cancer Center, Harbin Medical University Cancer Hospital, Nanchang People’s Hospital, Fujian Cancer Hospital, The First Affiliated Hospital, Zhejiang University School of Medicine, The Second Affiliated Hospital, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Beijing Cancer Hospital and The Second Affiliated Hospital of Dalian Medical University. All patients provided written informed consent before any procedure. The study was preregistered with clinical trial.gov on March 2019 with the registration number NCT03876587. Patients were provided with the study treatment for free and also received a transportation reimbursement.PANDORA is a multicenter, single-arm phase II trial with a Simon two-stage design, involving woman with HER2-positive MBC who had not received HER2 blockade or chemotherapy for metastatic disease between June 12, 2019 and June 18, 2021. The trial was conducted at 10 centers in China (Zhejiang Cancer Hospital, Sun Yat-sen University Cancer Center, Harbin Medical University Cancer Hospital, Nanchang People’s Hospital, Fujian Cancer Hospital, The First Affiliated Hospital, Zhejiang University School of Medicine, The Second Affiliated Hospital, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Beijing Cancer Hospital and The Second Affiliated Hospital of Dalian Medical University). Eligible patients met the following criteria: (1) histologically confirmed MBC and candidates for chemotherapy; (2) HER2-positive, defined as immunohistochemistry (IHC) staining 3+ or IHC staining 2+ with fluorescence in situ hybridization positive; (3) aged between 18 and 70 years old; (4) an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1; (5) at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; (6) may have received hormonal regimens in the metastatic setting; (7) (neo)adjuvant trastuzumab or taxane treatment was permitted, with a disease-free interval of more than 12 months from completion of the taxane and more than 6 months from completion of the trastuzumab. Patients who had previously received anti-HER2 TKI were excluded, as were those with CNS metastasis. Detailed inclusion and exclusion criteria can be found in the protocol.