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Trial Title:
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
NCT ID:
NCT05880927
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
Patients receive pyrotinib 400mg/day for half or one year
Arm group label:
Pyrotinib 400mg/day
Summary:
This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China.
High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year
for extented adjuvant therapy.
Detailed description:
Patients must meet one of the following criteria: N stage ≥1; T stage ≥2; did not achieve
pathological complete response (pCR) after neoadjuvant therapy; had pCR after neoadjuvant
therapy but with tumor size ≥ 5cm or N stage ≥2; or tumor size less than 2cm but with
high Ki67; histologic grade 3 or with lymph node micrometastasis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Women aged 18-75 years old
2. HER2 positive breast cancer
3. ECOG PS 0-1
4. Known hormone receptor status
5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months
6. Patients at high risk
Exclusion Criteria:
1. Serious heart disease or discomfort
2. Inability to swallow, intestinal obstruction, or the presence of other factors that
interfere with drug administration and absorption
3. Known allergic history of drug components of this regimen
4. A history of immunodeficiency, including HIV positive, or other acquired, congenital
immunodeficiency diseases, or a history of organ transplantation
5. Pregnant and lactating female patients
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Taizhou Hospital
Address:
City:
Taizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiqiang Xiao
Phone:
17757194561
Email:
zhiqiang.xiao@hengrui.com
Contact backup:
Last name:
Yan Luo
Phone:
13802214658
Email:
yan.luo.yl5@hengrui.com
Start date:
January 1, 2019
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Taizhou Hospital
Agency class:
Other
Source:
Taizhou Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05880927
