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Trial Title:
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
NCT ID:
NCT05834764
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Maleic acid
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:
Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）
Arm group label:
Pyrotinib
Other name:
Pyrotinib maleate
Summary:
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy
found that it can improve disease-free survival in patients with lymph nodes positive; In
addition, the subgroup of patients with residual tumors after neoadjuvant therapy was
found to improve the survival. However, no conclusive conclusions were reached.
However, since the study was carried out early so only trastuzumab treatment was used, it
is urgent to carry out research that is more in line with current clinical practice and
bring more benefits to patients. To explore whether pyrotinib can further reduce the risk
of recurrence from previously diagnosed HER2-positive breast cancer after treatment with
trastuzumab and pertuzumab or T-DM1.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects voluntarily participate in this study and sign the informed consent form；
2. Female or male patients, aged ≥ 18 years, and ≤75 years;
3. ECOG PS score: 0-1;
4. Patients with HER2+ early or locally advanced breast cancer confirmed by
histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical
staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ
hybridization (ISH).
5. Stage II through IIIC HER-2 positive breast cancer with node positive disease after
surgery.
6. Been treated for early breast cancer with standard of care duration of trastuzumab
combined with pertuzumab or T-DM1.
7. Could have been treated neoadjuvantly but have not reached pathologic complete
response.
Exclusion Criteria:
1. metastatic disease (Stage IV) or inflammatory breast cancer
2. Previous or current history of malignant neoplasms, except for curatively
treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the
cervix.
3. Clinically relevant cardiovascular disease:Known history of uncontrolled or
symptomatic angina, clinically significant arrhythmias, congestive heart failure,
transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. A history of allergy to the drugs in this study；
5. Unable or unwilling to swallow tablets
6. History of gastrointestinal disease with diarrhea as the major symptom.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoan Liu, Professor
Phone:
025-68308162
Email:
liuxiaoan@126.com
Start date:
April 8, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05834764
