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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03919253
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
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.

Information from the National Library of Medicine

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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

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 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
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Maleic acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors