Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer: a Multicenter, Observational, Real-world Study
This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.
• age ≥ 18 years, postmenopausal or premenopausal female or male patients, female patients must meet one of the following: a) previous bilateral oophorectomy, or age ≥ 60 years; b) age \< 60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; c) premenopausal or perimenopausal female patients can also be enrolled, but must be willing to receive LHRH agonist therapy during the study;
• pathological examination confirmed HR-positive male/female breast cancer patients, with evidence of focal recurrence or metastasis, not suitable for surgical resection or radiation therapy with the purpose of cure;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Serum pregnancy test must be performed within 28 days before enrollment in women of childbearing age and the result is negative,And male/female patients are willing to use a medically recognized highly effective contraceptive during the study and within 1 year after the last dose of study drug;
• non-pregnant or non-lactating female patients；
• do not participate in other ongoing studies at the same time ；
• agreed by the patient himself or her legal representative and have signed an informed consent form, willing and able to comply with scheduled visits, study treatment plan, laboratory tests and other trial procedures.