NCT04717531

Pyrotinib as Neoadjuvant Agent for Non-objective Response HER2-positive Early Breast Cancer

Pyrotinib as Neoadjuvant Agent for Non-objective Response Patients of HER2-positive Early Breast Cancer Treated by Trastuzumab, Pertuzumab, and Chemotherapy (PYHOPE-BC-104): a Randomized, Controlled, Phase Ⅱ Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study assesses the efficacy of neoadjuvant treatment with pyrotinib and trastuzumab with chemotherapy, mainly pathological complete response (pCR) rates in the breast and axilla. And also assesses side effects, event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and objective response rates (ORR).

Detailed description

Investigational Medical Products (IMPs) will be pyrotinib (B), trastuzumab (H), pertuzumab (P), docetaxel (T), epirubicin (E), and cyclophosphamide (C). Magnetic resonance imaging (MRI) will be performed at baseline and 2 cycles after neoadjuvant therapy with trastuzumab, pertuzumab, and docetaxel (THP\*2). Non-objective response patients will be randomly assigned (2:1) to receive 2 cycles of pyrotinib and trastuzumab with docetaxel followed by 4 cycles of pyrotinib and epirubicin plus cyclophosphamide (THB\*2-ECB\[epirubicine, cyclophosphamide, and pyrotinib\]\*4, cohort A), or 2 cycles of trastuzumab and pertuzumab with docetaxel followed by 4 cycles of epirubicin plus cyclophosphamide (THP\*2-EC\*4, cohort B). During the neoadjuvant therapy, the side effects and all the events were recorded and analyzed. After surgery, the efficacy of pCR rate and ORR were analyzed. And long time follow-up will also be performed to analyze EFS, DFS, DDFS, and ORR.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	400mg, qd, po, day 1-21
DRUG	Trastuzumab	6 mg/kg, day 1
DRUG	Pertuzumab	420 mg, day 1
DRUG	Docetaxel	100 mg/m2, day 1
DRUG	Epirubicin	90mg/m2, day 1
DRUG	Cyclophosphamide	600 mg/m2, day 1

Timeline

• Start date: 2021-06-03
• Primary completion: 2023-06-01
• Completion: 2024-05-31
• First posted: 2021-01-22
• Last updated: 2021-06-04

Locations

1 site across 1 country: China