Study design and patients
ovarian function, Cancer, HER2-positive, Tumors
METASTASIS, DISEASE, METASTATIC DISEASE, TUMORS, CANCER
In this multicenter, single-arm, open-label phase II trial, patients with HER2-positive and HR-positive MBC who had not received treatment for metastasis disease from seven centers in China were included. The inclusion criteria were (1) aged 18 ~ 70 years; (2) histologically or cytologically confirmed MBC; (3) ER-positive confirmed by immunohistochemistry (IHC), with ≥ 10% positive cells (local laboratory assessment); (4) HER2-positive, defined as IHC 3 + or IHC 2 + with fluorescence in situ hybridization (FISH) positivity; (5) prior (neo)adjuvant trastuzumab, pertuzumab or chemotherapy were eligible; if indicated, the disease free interval (DFI) must be greater than 12 months from completion of (neo)adjuvant trastuzumab and pertuzumab; (6) patients either pre-, peri-, or post-menopausal were eligible, and ovarian function suppression (OFS) should be combined in case of pre- or peri-menopausal; (7) had at least one measurable metastatic disease according to the Response Evaluation Criteria In Solid Tumors, version 1.1 (RECIST v1.1) [All enrolled patients provided the informed consent forms. The study was approved by the ethics committee of Hunan Cancer Hospital, and conducted in accordance with the Declaration of Helsinki, guidelines of the International Conference for Harmonization and Good Clinical Practice, as well as local ethical and legal requirements. This trial was registered at ClinicalTrials.gov (NCT04407988).