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Trial Title:
Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer
NCT ID:
NCT05841381
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Trastuzumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
pyrotinib: 400mg orally daily for 1 year
Arm group label:
arm 1
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 17 cycles
Arm group label:
arm 1
Arm group label:
arm 2
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
80mg/m2 per week for a total of 12 weeks
Arm group label:
arm 1
Arm group label:
arm 2
Summary:
This is an open label, phase III study evaluating the efficacy and safety of Pyrotinib in
Combination With Trastuzumab and paclitaxel in patients HER2 Positive and lymph node
negative invasive Breast Cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Females 18-70 years old;
- Pathological confirmed of stage I-II breast cancer: histologically confirmed that
the longest diameter of invasive cancer is no less than 1cm and no more than 5cm and
the lymph node is negative (N0);
- The pathological type of immunohistochemistry must meet the following conditions:
HER-2 (3+) or HER-2 (0-2 +) with FISH detection is amplified;
- For patients with invasive lesions on both sides, if both lesions are HER-2 positive
and meet the tumor size requirements, then can be enrolled;
- Has adequate organ function meeting the following criteria: (1) adequate bone marrow
function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute
neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver
and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN),
Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum
creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of >50 ml/min
(Cockcroft-Gault formula);
- LVEF>50%;
- The patient voluntarily joined the study, signed the informed consent form, had good
compliance, and cooperated with the follow-up.
Exclusion Criteria:
- Has received neoadjuvant therapy (include chemotherapy, targeted therapy,
radiotherapy or endocrine therapy;
- Has previous history of additional malignancy, with the exception of adequately
treated basal cell carcinoma and cervical carcinoma in situ;
- Has metastic (Stage 4) breast cancer;
- Pregnant or breast feeding women, or women of childbearing age who cannot practice
effective contraceptives;
- Patients participating in other clinical trials at the same time;
- Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left
ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio
cerebral vascular disease within the 6 months previous of randomization (such as
unstable angina, chronic heart failure, uncontrolled hypertension with blood
pressure>150/90mmHg, myocardial infarction, or cerebral blood vessel); diabetic
patients with poor blood glucose control; patients with severe hypertension;
- Has severe or uncontrolled infection;
- Has a history of psychotropic substance abuse and were unable to abandon drug
habits, or those with history of mental disorders;
- The researchers considered patients to be unsuitable for the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
May 6, 2023
Completion date:
May 6, 2033
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05841381
