This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice.
This study is a single-arm, open-label, multicenter, phase II clinical study. Subjects were eligible for screening and entered the trial period after enrollment and received treatment with pyrotinib(320mg/day), trastuzumab(8 mg→6mg/every 3 week), dalpiciclib(125mg once daily for 3 weeks, followed by 1 week off in each 4-week cycle), endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. On-study imaging assessments were performed according to RECIST 1.1 criteria and the site assessment was final.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Trastuzumab (8-6mg/3weekly),Pyrotinib(320mg/day)Dalpiciclib(125mg/day,With three weeks separated by one week)
ORR
Time frame: 8week
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