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Trial Title:
A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
NCT ID:
NCT06470347
Condition:
HER-2 Positive Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Study type:
Interventional
Study phase:
Phase 1/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:
A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
Description:
During treatment, subjects were given 400 mg pyrrotinib once daily, within 30 minutes
after breakfast.
Arm group label:
pyrrolitinib
Other name:
pyrrolitinib
Summary:
Purpose of the Study:
Primary Study Objective:
To evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of
HER-2-positive early or locally advanced breast cancer after adjuvant therapy with
trastuzumab
Secondary Research Objectives:
To evaluate the safety of pyrrolitinib maleate tablets in the treatment of HER-2 positive
early or locally advanced breast cancer after trastuzumab adjuvant therapy
Study Endpoints Primary Study Endpoint:
Invasive disease free survival (iDFS)
Secondary Study Endpoints:
1. overall survival (OS);
2. disease-free survival (DFS);
3. distant metastasis free survival (DDFS);
4. safety Study Population: Patients with early or locally advanced HER-2 positive
breast cancer with clinical stage 0-III who have received prior neoadjuvant or
adjuvant therapy. where the neoadjuvant and/or adjuvant treatment phase has been
completed at least ≥24 weeks (8 dosing cycles) of trastuzumab therapy and the time
interval between the end of the last course of trastuzumab therapy and entry into
the study must be ≤1 year Study Design: Single-arm, multicenter, interventional
study Administration Pyrrolitinib: The recommended dose of this product is 400 mg
orally once daily within 30 minutes after breakfast for 52 weeks (approximately one
year).
Dose adjustments may be made in accordance with this protocol, taking into account
adverse reactions in subjects. Each consecutive suspension of piretinib during the course
of the study should not exceed 14 days, prophylactic use of medications for the treatment
of diarrhea is permitted during the course of treatment, multiple suspensions of study
medication due to adverse events are permitted, and doses of piretinib that are missed
for any reason will not be made up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age: 18-75 years;
- Invasive breast cancer with clinical stage 0-III and treated surgically;
- Histopathologically confirmed HER-2 positivity: immunohistochemistry (IHC) result of
3+ or in situ hybridization (ISH) result of HER-2 gene amplification (HER-2/CEP17 ≥
2.0 or average HER-2 copy number/cell ≥ 6);
- Have undergone radical mastectomy or breast-conserving surgery for breast cancer,
with no cancer left in the body and no recurrence of metastatic disease after
surgery:
1. Pathologic test confirms that there is no residual invasive cancer at the
margins and no residual ductal carcinoma in situ;
2. Patients who have not received neoadjuvant therapy should have negative
surgical margins, and there is no requirement for the presence of lymph node
metastasis (including the presence of lymph node micrometastasis) suggested by
postoperative pathological tests;
3. Patients receiving neoadjuvant therapy are not allowed to have postoperative
pathologic evidence of invasive carcinoma in the breast or axillary lymph
nodes;
- Previous trastuzumab anti-HER-2 therapy: completion of ≥24 weeks (8 dosing cycles)
of trastuzumab in the neoadjuvant and/or adjuvant phases; the interval between the
end of the last course of trastuzumab therapy and entry into the study must be ≤1
year.
- Known hormone receptor status (ER/PR);
- ECOG score of 0-1;
Normal function of major organs:
1. Blood count:
Neutrophils (ANC) ≥ 1.5 x 109/L; Platelet count (PLT) ≥90×109/L; Hemoglobin (Hb) ≥90
g/L;
2. Blood biochemistry:
Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; Alkaline phosphatase ≤ 2.5 x
ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN;
3. Cardiac ultrasound:
Left ventricular ejection fraction (LVEF) ≥55%;
4. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 msec.
- For female patients who are not menopausal or surgically sterilized: consent to
abstinence or use of an effective non-hormonal pharmacologic method of
contraception for the duration of treatment and for 8 weeks after the last dose
of study treatment;
- Benefit in the opinion of the investigator;
- Voluntarily participate in the study by signing an informed consent form.
Exclusion Criteria:
- Confirmed local/regional recurrence/metastasis at enrollment;
- Prior anti-HER-2 therapy with pyrrolitinib, lenatinib, lapatinib and other tyrosine
kinase inhibitors;
- History of gastrointestinal disease with diarrhea as the primary symptom;
- Psychiatric illness or psychotropic substance abuse that prevents cooperation;
- Female patients who are pregnant or breastfeeding;
- Those who, in the opinion of the investigator, are not suitable for enrollment.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Zunyi Medical University
Address:
City:
Zunyi
Country:
China
Status:
Recruiting
Contact:
Last name:
junyuan LV, Doctor of Medicine
Phone:
19185126262
Email:
junyuanlv@zmu.edu.cn
Start date:
November 1, 2022
Completion date:
November 1, 2025
Lead sponsor:
Agency:
Zunyi Medical College
Agency class:
Other
Source:
Zunyi Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06470347
http://dx.doi.org/10.21037/tbcr-20-25
