HER2-positive Breast Cancer Clinical Trial
Official title:
Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study
Verified date | April 2019 |
Source | Hebei Medical University Fourth Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hebei Medical University Fourth Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progress-free survival(PFS) | Baseline to measured date of progress or death from any cause | three years | |
Secondary | Objective response rate (ORR) | Baseline to measured stable disease | three years | |
Secondary | Clinical Benefit Rate (CBR) | The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks | three years | |
Secondary | Disease control rate(DCR) | Rate of the patients with disease control | three years | |
Secondary | Overall survival (OS) | Baseline to measured date of death from any cause | up to death | |
Secondary | Safety (number of Participants with adverse events) | 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. | three years |
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