Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Not yet enrolling

Phase 2

Conditions

Early Breast Cancer

Treatments

Drug: Nab-paclitaxel in combination with pyrotinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04659499

MA-BC-II-007

Details and patient eligibility

About

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.

Enrollment

261 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 1.
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.
Previous history of definite neurological or psychiatric disorders.
Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval.