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Phase II Open-label, Multicentre, Exploratory Trial of Neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
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.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Start Date
September 1, 2022
Primary Completion Date
December 1, 2024
Completion Date
December 1, 2024
Last Updated
February 21, 2023
30
ESTIMATED participants
Trastuzumab Pyrotinib Exemestane Dalpiciclib
DRUG
Luyan Chen, Doctor
CONTACT
Lead Sponsor
First Affiliated Hospital of Zhejiang University
NCT04550494
NCT05372640
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