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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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

Clinicaltrials.gov identifier NCT03919253

Recruitment Status Not yet recruiting

First Posted April 18, 2019

Last update posted April 18, 2019

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:HER2-positive Breast Cancer
  • Intervention/Treatment: Combination Product: pyrotinib maleate tablets+nab-paclitaxel
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: April 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
  • Ages Eligible for Study: 18 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
Contacts
Locations
Sponsors and Collaborators

Hebei Medical University Fourth Hospital

More Information
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms