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

Early Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04659499
• Other study ID #: MA-BC-II-007
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2021
• Est. completion date: June 2025

Study information

• Verified date: November 2020
• Source: Peking Union Medical College Hospital
• Contact: Qiang Sun, MD
• Phone: +861069152700
• Email: sunqiangpumc[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 261
• Est. completion date: June 2025
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Drug:
• Nab-paclitaxel in combination with pyrotinib
Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year-DFS	3-years-disease free survival rate	From the start of treatment to 3 years
Secondary	AEs+SAEs	Adverse Events and Serious Adverse Events are described in terms of CTC AE 5.0	from the first drug administration to within 28 days for the last pyrotinib dose