A Multicenter, Open-label, Single-arm, Phase II Clinical Trial of Nab-paclitaxel in Combination With Pyrotinib in Adjuvant Therapy for Lymph Node-negative and Small Tumor HER2-positive Breast Cancer

Peking Union Medical College Hospital0 sites261 target enrollmentJanuary 2021

ConditionsEarly Breast Cancer

InterventionsNab-paclitaxel in combination with pyrotinib

DrugsNab-paclitaxel in combination with pyrotinib

Overview

Phase: Phase 2
Intervention: Nab-paclitaxel in combination with pyrotinib
Conditions: Early Breast Cancer
Sponsor: Peking Union Medical College Hospital
Enrollment: 261
Primary Endpoint: 3-year-DFS
Status: Not yet recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, open-label, single-arm, prospective, phase II study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, HER2 positive breast cancer.

Registry

clinicaltrials.gov

Start Date

January 2021

End Date

June 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Enrollment subjects must have a pathological diagnosis of HER2-positive primary invasive breast cancer with an immunohistochemistry (IHC) score of 3 +, or 2 + and HER2 gene amplification by in situ hybridization (ISH) (ratio of HER2/CEP17 ≥ 2.0).
•The invasive tumor had to measure no more than 3cm and with histologically confirmed lymph node-negative or one lymph node micrometastasis (T ≤ 3 cm, N0/N1mi, M0).
•Tumor should has known ER/PR hormone receptor status.
•All patients must be women above18 years old with Eastern Cooperative Oncology Group score 0 to
•Adequate hematopoietic function and organ function as defined as follows: neutrophil count ≥ 1.5 x 109/L; Platelet count ≥ 90 × 109/L; Hemoglobin ≥ 90 g/L; total bilirubin ≤ 1.5 × ULN; alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN; serum creatinine Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula).
•left ventricular ejection fraction (LVEF) ≥ 50% and Electrocardiogram Fridericia-corrected QT interval (QTcF) ≤ 480 ms.
•Provide written informed consent.

Exclusion Criteria

•Clinical or radiologic evidence of local or regional recurrence of disease or metastatic disease prior to or at the time of study entry.
•Previous treatment with chemotherapeutic drugs, or tyrosine kinase inhibitors targeting HER2 (lapatinib, neratinib or pyrotinib, etc.).
•Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
•Inability to swallow, chronic diarrhea, or intestinal obstruction.
•Known to be allergic to the drug components.
•Have a history of immunodeficiency, including HIV positive, HCV positive, active viral hepatitis B or other immunodeficiency diseases.
•Have a history of organ transplantation.
•Pregnant, lactating female patients, or female patients who are unwilling to take effective contraceptive.
•Any heart disease, including: (1) arrhythmia; (2) myocardial infarction; (3) heart failure.
•Any other concomitant diseases assessed by investigator as unsuitable for study.