This is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.
This is a phase II open-label, multicenter trial. The study assesses the treatment of patients with ER-positive /HER2 positive early breast cancer with neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab plus Pyrotinib. Patients were treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21,Q4W) and Exemestane (25 mg po QD )and oral pyrotinib (320 mg po QD) for 20 weeks. The primary endpoints was pathological complete response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Early triple positive breast cancer patients receive combination regimen of Dalpiciclib in Combination With Exemestane and Trastuzumab plus pyrotinib
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGpathological complete response (pCR)
Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery
Time frame: at surgery
Serial measures of Ki67
Changes in Ki67 scores from baseline before therapy, 2 weeks after and then at surgery
Time frame: baseline before therapy, 2 weeks after and at surgery
Objective response
Defined as the number of patients with partial or complete response according to RECIST 1.1
Time frame: Tumour assessments will be performed by ultrasound and mammography at screening (prior to start of treatment), and before surgery, an expected average of 24 weeks
Luyan Chen, Doctor
CONTACT
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