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

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ClinicalTrials.gov Identifier: NCT03919253
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Fourth Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

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.




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.



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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.

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Responsible Party: Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT03919253     History of Changes
Other Study ID Numbers: HBBL-01
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Maleic acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors