- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03919253
Recruitment Status Not yet recruiting
First Posted April 18, 2019
Last update posted April 18, 2019
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.
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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.
- 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.
Hebei Medical University Fourth Hospital