This is a single-center Ib / II study of triple targeted drug combination (endocrine
therapy，novel HER2-targeted small molecule inhibitor pyrotinib and CDK4/6 inhibitor
dalpiciclib(SHR6390) ) as a first or second line of therapy in patients with
relapsed/metastatic hormone receptor positive and HER2-positive breast cancer.
This is a single-center, single arm, open-label, run-in phase Ib / roll-over phase II study
of endocrine therapy in combination with novel human epidermal growth factor
receptor-2(HER2)-targeted tyrosine kinase Inhibitor pyrotinib and cyclin-dependent kinase
4/6(CDK4/6) Inhibitor dalpiciclib(SHR6390) in subjects with hormone receptor(HR)+/HER2+
relapsed or metastatic breast cancer. The study will enroll natural postmenopausal women, or
women who have undergone bilateral oophorectomy.The phase Ib part of the study will determine
safety and tolerability of the combination of endocrine therapy, pyrotinib and dalpiciclib to
define that appropriate dose of dalpiciclib for phase II.Data from phase Ib showed the
triplet of pyrotinib, dalpiciclib, andendocrine therapy had an acceptable safety profile and
encouraging efficacy, potentially offering a chemotherapy-sparing treatment option for
patients with HER2-positive/HR-positive MBC.Once the recommended regimen has been identified,
subjects with the selected tumor type will be enrolled into expansion cohorts for the purpose
of assessing efficacy and safety of the combination treatment.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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