A Study of Pyrotinib Plus Vinorelbine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
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Keep this study
Lead
Sun Yat-sen University
With
Jiangsu HengRui Medicine Co., Ltd.
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results
Histologically or cytologically confirmed invasive breast cancer
Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent
Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator
Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded
Cardiac ejection fraction greater than or equal to (\>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You may not be if
History of treatment with pyrotinib
Prior treatment with lapatinib or neratinib
History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma
History of receiving any anti-cancer drug/biologic or investigational treatment within 28 days prior to randomization except hormone therapy
Recovery of treatment-related toxicity consistent with other eligibility criteria
History of radiation therapy within 28 days of randomization
Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization
History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
History of myocardial infarction or unstable angina
Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
Pregnancy or lactation
Current known active infection with human immunodeficiency virus (HIV) or hepatitis C virus
Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
Clareo Health | A Study of Pyrotinib Plus Vinorelbine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
