NCT04659499
Not yet recruiting
Phase 2
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
ConditionsEarly Breast Cancer
InterventionsNab-paclitaxel in combination with pyrotinib
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 261
- Primary Endpoint
- 3-year-DFS
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Nab-paclitaxel in combination with pyrotinib treatment group
Experimental
Nab-paclitaxel 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib 240mg daily for one year
Intervention: Nab-paclitaxel in combination with pyrotinib (Drug)
Outcomes
Primary Outcomes
3-year-DFS
Time Frame: From the start of treatment to 3 years
3-years-disease free survival rate
Secondary Outcomes
- AEs+SAEs(from the first drug administration to within 28 days for the last pyrotinib dose)
Investigators
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