Clareo Health | A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult participants ≥ 18 years of age.
Histologically or cytologically documented breast cancer.
Metastatic or unresectable locally advanced/recurrent breast cancer.
HER2-positive disease by prospective laboratory confirmation.
Disease progression on the last regimen received as defined by the investigator.
Prior treatment with an trastuzumab, a taxane, and lapatinib.
Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
Adequate organ function, as evidenced by laboratory results.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multi gated acquisition scan.
You may not be if
Chemotherapy ≤ 21 days before first study treatment.
Trastuzumab ≤ 21 days before first study treatment.
Lapatinib ≤ 14 days before first study treatment.
Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.
Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.
