This study is a prospective, single-arm, phase II clinical study for patients with ER+/HER2+ advanced breast cancer.
Patients with ER+/HER2+ advanced breast cancer are planned to be enrolled. Patients will receive first-line endocrine therapy combined with anti-HER2 therapy. The main purpose is to evaluate whether disease-free intervals can guide first-line endocrine combined targeted therapy for ER+/HER2+ advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
8 mg/kg loading dose IV, then 6 mg/kg IV, every 3 weeks
Pyrotinib 320mg, PO daily, continuously
Dalpiciclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China
PFS
time to progressive disease (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 5 years)
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 5 years)
CBR
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 5 years)
DOR
Duration of whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 5 years)
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Fulvestrant will be given intramuscle at the dose of 500 mg every 4 weeks (with an additional 500 mg dose given two weeks after the initial dose.