A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab，Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer

Wuhan Union Hospital, China2 sites in 1 country62 target enrollmentMay 11, 2023

ConditionsBreast Cancer Neoadjuvant

Interventionspyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel

Drugspyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel

Overview

Phase: Phase 2
Intervention: pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel
Conditions: Breast Cancer
Sponsor: Wuhan Union Hospital, China
Enrollment: 62
Locations: 2
Primary Endpoint: total Pathological Complete Response(tPCR)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.

Registry

clinicaltrials.gov

Start Date

May 11, 2023

End Date

May 11, 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Wuhan Union Hospital, China

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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;

Arms & Interventions

pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel

Pyrotinib tablets: 320mg qd, 21 days for 1 cycle, continuous administration of 6 cycles. Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days was 1 cycle, continuous administration of 6 cycles. Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days for 1 cycle, and 6 consecutive cycles were given. Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula, with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles of administration

Intervention: pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel