To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment for 4 cycles
Anastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered)
Pyrotinib 400mg once daily for 16 weeks
Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy
Ki67 changes from baseline to at 2 weeks after the start of the neoadjuvant therapy
Time frame: 2 weeks
Ki67 changes from baseline to at surgery
Ki67 changes from baseline to at surgery
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Pathological complete response (ypT0/is ypN0) rate
Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Objective response rate (ORR)
ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Invasive disease-free survival (IDFS)
IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)
Time frame: 5 years
Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped
Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Time frame: during treatment (16 weeks)
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Trastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles.