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出境医 / 临床实验 / Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study

Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study

Study Description
Brief Summary:
This clinical trial aim to evaluate the efficacy and safety of Pyrotinib in combination with nab-paclitaxel in patients with HER2-positive advanced breast cancer.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Combination Product: pyrotinib maleate tablets+nab-paclitaxel Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: pyrotinib maleate tablets+nab-paclitaxel
pyrotinib maleate tablets: 400mg orally once daily continunously; nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.
 Combination Product: pyrotinib maleate tablets+nab-paclitaxel
pyrotinib maleate tablets: 400mg orally once daily continunously nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.
Outcome Measures
Primary Outcome Measures :
  1. Progress-free survival(PFS) [ Time Frame: three years ]
    Baseline to measured date of progress or death from any cause


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: three years ]
    Baseline to measured stable disease

  2. Clinical Benefit Rate (CBR) [ Time Frame: three years ]
    The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks

  3. Disease control rate(DCR) [ Time Frame: three years ]
    Rate of the patients with disease control

  4. Overall survival (OS) [ Time Frame: up to death ]
    Baseline to measured date of death from any cause

  5. Safety (number of Participants with adverse events) [ Time Frame: three years ]
    Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The number of Participants with adverse events will be recorded at each treatment visit.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age: 18-70 years old，female; 2. Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) 3. Imaging examination confirmed recurrent/metastatic breast cancer； 4. Patients must have previous treatment with trastuzumab more than 9 weeks; 5. Untreated for metastatic/metastatic disease (except for endocrinotherapy); 6. Patients with at least one measurable lesions by RECIST version 1.1； 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2； 8. Life expectancy greater than or equal to 3 months; 9. Participants must have normal organ and marrow function as described below： Absolute neutrophil count≥1.5×109/L; Platelets≥90×109/L; Hemoglobin ≥90g/L； Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)； ALT and AST≤2*ULN, but ≤5*ULN with liver metastases; BUN and Cr≤1.5×ULN or creatinine clearance ≥50ml/min Left ventricular ejection fraction (LVEF) ≥ 50% 10. Doctors believe that treatment can bring benefits to patients； 11. Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

  • 1. A variety of factors influencing oral drugs (after resection of the gastrointestinal, unable to swallow, Chronic diarrhea, intestinal obstruction); 2. Patients with other malignant tumors within 5 years (except for skin basal cell carcinoma and cervical carcinoma in situ); 3. History of psychiatric drugs abuse or patients with mental disorders; 4. Pregnant or lactating women; 5. Less than 4 weeks from the last clinical trial 6. The researchers think inappropriate.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date April 18, 2019
Estimated Study Start Date  ICMJE April 30, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		Progress-free survival(PFS) [ Time Frame: three years ]
Baseline to measured date of progress or death from any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Objective response rate (ORR) [ Time Frame: three years ]
    Baseline to measured stable disease
  • Clinical Benefit Rate (CBR) [ Time Frame: three years ]
    The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks
  • Disease control rate(DCR) [ Time Frame: three years ]
    Rate of the patients with disease control
  • Overall survival (OS) [ Time Frame: up to death ]
    Baseline to measured date of death from any cause
  • Safety (number of Participants with adverse events) [ Time Frame: three years ]
    Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The number of Participants with adverse events will be recorded at each treatment visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study
Official Title  ICMJE Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study
Brief Summary This clinical trial aim to evaluate the efficacy and safety of Pyrotinib in combination with nab-paclitaxel in patients with HER2-positive advanced breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HER2-positive Breast Cancer
Intervention  ICMJE Combination Product: pyrotinib maleate tablets+nab-paclitaxel
pyrotinib maleate tablets: 400mg orally once daily continunously nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.
Study Arms  ICMJE Experimental: pyrotinib maleate tablets+nab-paclitaxel
pyrotinib maleate tablets: 400mg orally once daily continunously; nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.
Intervention: Combination Product: pyrotinib maleate tablets+nab-paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Age: 18-70 years old，female; 2. Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) 3. Imaging examination confirmed recurrent/metastatic breast cancer； 4. Patients must have previous treatment with trastuzumab more than 9 weeks; 5. Untreated for metastatic/metastatic disease (except for endocrinotherapy); 6. Patients with at least one measurable lesions by RECIST version 1.1； 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2； 8. Life expectancy greater than or equal to 3 months; 9. Participants must have normal organ and marrow function as described below： Absolute neutrophil count≥1.5×109/L; Platelets≥90×109/L; Hemoglobin ≥90g/L； Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)； ALT and AST≤2*ULN, but ≤5*ULN with liver metastases; BUN and Cr≤1.5×ULN or creatinine clearance ≥50ml/min Left ventricular ejection fraction (LVEF) ≥ 50% 10. Doctors believe that treatment can bring benefits to patients； 11. Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

  • 1. A variety of factors influencing oral drugs (after resection of the gastrointestinal, unable to swallow, Chronic diarrhea, intestinal obstruction); 2. Patients with other malignant tumors within 5 years (except for skin basal cell carcinoma and cervical carcinoma in situ); 3. History of psychiatric drugs abuse or patients with mental disorders; 4. Pregnant or lactating women; 5. Less than 4 weeks from the last clinical trial 6. The researchers think inappropriate.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919253
Other Study ID Numbers  ICMJE HBBL-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hebei Medical University Fourth Hospital
Study Sponsor  ICMJE Hebei Medical University Fourth Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hebei Medical University Fourth Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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