Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04929548 |
Other study ID # |
WuhanU |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
January 5, 2022 |
Est. completion date |
September 20, 2027 |
Study information
Verified date |
January 2022 |
Source |
Wuhan University |
Contact |
Hou jinxuan |
Phone |
+86 13971431260 |
Email |
jhou[@]whu.edu.cn |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study is a single-arm, single-center exploratory clinical study. Twenty patients with
early-stage HER2-positive breast cancer are planned to be included, and the primary objective
is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with
trastuzumab + pertuzumab.
Description:
Recruiting patients with clinical stage II to III HER2-positive breast cancer for primary
treatment, eligible subjects will be enrolled as follows: This study is a single-arm,
single-center exploratory clinical study. Twenty patients with early-stage HER2-positive
breast cancer are planned to be included, and the primary objective is to evaluate the
efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab +
pertuzumab.Eligible subjects who met the enrollment criteria and signed the informed consent
form entered the trial period and received epirubicin 100 mg/m2, iv cyclophosphamide 600
mg/m2, iv + Pyrotinib 400 mg/d, po for 4 weeks, sequential docetaxel 80 mg/m2, iv +
trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + pertuzumab 420 mg (first dose 840 mg), iv ,po
4 cycles of treatment. Surgery was performed at the end of the above treatment cycles, and
adjuvant targeted therapy was continued after surgery: trastuzumab + patuximab for 1 year.
Eligible subjects (20) who met the nadir criteria and signed the informed consent form
entered the trial period and received the ECPy-THP regimen: i.e., epirubicin 100 mg/m2, iv +
cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po 4 cycles, sequential docetaxel 80
mg/m2, iv + trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + patuximab 420 mg (first dose 840
mg), iv, po 4 cycles of treatment. If the efficacy of 4 cycles was evaluated as PD or SD, the
regimen was promptly adjusted for surgical treatment.
Surgery was performed at the end of the above treatment cycles, and adjuvant targeted therapy
was continued after surgery: patients who reached pCR continued trastuzumab + pertuzumab for
1 year, and non-pCR patients were treated according to the guideline-recommended backline
regimen.
All patients underwent surgery or radiotherapy continuation within 16-20 d after completion
of the neoadjuvant chemotherapy cycle, and the efficacy was assessed 1 to 2 d before
continuation of treatment.