Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer
Primary Purpose
Early Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nab-paclitaxel in combination with pyrotinib
Sponsored by
About this trial
This is an interventional treatment trial for Early Breast Cancer
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nab-paclitaxel in combination with pyrotinib treatment group
Arm Description
Nab-paclitaxel 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib 240mg daily for one year
Outcomes
Primary Outcome Measures
3-year-DFS
3-years-disease free survival rate
Secondary Outcome Measures
AEs+SAEs
Adverse Events and Serious Adverse Events are described in terms of CTC AE 5.0
Full Information
NCT ID
NCT04659499
First Posted
December 2, 2020
Last Updated
December 2, 2020
Sponsor
Peking Union Medical College Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04659499
Brief Title
Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
261 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nab-paclitaxel in combination with pyrotinib treatment group
Arm Type
Experimental
Arm Description
Nab-paclitaxel 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib 240mg daily for one year
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel in combination with pyrotinib
Intervention Description
Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year
Primary Outcome Measure Information:
Title
3-year-DFS
Description
3-years-disease free survival rate
Time Frame
From the start of treatment to 3 years
Secondary Outcome Measure Information:
Title
AEs+SAEs
Description
Adverse Events and Serious Adverse Events are described in terms of CTC AE 5.0
Time Frame
from the first drug administration to within 28 days for the last pyrotinib dose
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Sun, MD
Phone
+861069152700
Email
sunqiangpumc@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Changjun Wang, MD
Phone
+861069158721
Email
wangchangjun@pumch.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
35287613
Citation
Wang C, Zhou Y, Lin Y, Mao F, Guan J, Zhang X, Shen S, Wang X, Zhang Y, Pan B, Zhong Y, Peng L, Cao X, Yao R, Zhou X, Xu C, Xu Y, Sun Q. Rationale and design of a phase II trial of pyrotinib in combination with nab-paclitaxel as adjuvant therapy for N0/N1mi, HER2 + early breast cancer (PHAEDRA). BMC Cancer. 2022 Mar 14;22(1):269. doi: 10.1186/s12885-022-09346-1.
Results Reference
derived
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Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer
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