Status:
RECRUITING
A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER2+ Breast Cancer
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Breast Cancer
Neoadjuvant
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This study is a multicenter, single-arm, prospective, open clinical study to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and carboplatin in neoad...
Eligibility Criteria
Inclusion
- Newly treated female patients aged ≥18 years and ≤75 years;
- ECOG score 0\~1;
- Pathologically diagnosed as HER2-positive breast cancer patients with early or locally advanced tumor stage, primary tumor diameter T≥2cm or lymph node positive;
- Hormone receptor status (ER and PgR) is known, where ER≥10%
- Normal function of major organs:
- The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT≥90×109/L; Hb ≥90g/L
- Biochemical examination should meet the following standards: TBIL≤ the upper limit of normal value(ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula);
- Cardiac color ultrasound and echocardiography: left ventricular ejection fraction(LVEF≥55%)
- Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms;
- For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment;
- Volunteer to join the study and sign the informed consent.
Exclusion
- Stage IV (metastatic) breast cancer;
- Inflammatory breast cancer;
- Previous antitumor therapy or radiation therapy for any malignancies, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma;
- Also receiving antitumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
- Had a major surgery not related to breast cancer in the 4 weeks prior to enrollment, or had not fully recovered from such surgery;
- Serious heart disease or discomfort, including but not limited to the following:
- History of heart failure or systolic dysfunction (LVEF \< 50%)
- High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \>100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-grade atrioventricular block (i.e. Mobitz II second- degree atrioventricular block or third-degree atrioventricular block
- Inability to swallow, intestinal obstruction, or other factors affecting the use and absorption of the drug;
- Known allergic history of the drug components of this protocol; A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- Women who are pregnant or nursing, women who are fertile and have a positive baseline pregnancy test, or women of childbearing age who are unwilling to use effective contraception throughout the trial period and within 7 months after the last study medication;
- Have a serious concomitant condition or other comorbid condition that interferes with planned treatment, or any other condition in which the investigator deems the patient unsuitable for participation in the study.
Key Trial Info
Start Date :
May 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 11 2028
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06000917
Start Date
May 11 2023
End Date
May 11 2028
Last Update
August 21 2023
Active Locations (2)
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1
WuhanHU
Wuhan, Hubei, China, 430000
2
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China