Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically centrally confirmed HER2-positive (immunohistochemistry \[IHC\]3+ in greater than or equal to \[\>/=\] 30 percent \[%\] of tumor cells): locally advanced (unresectable and not treatable with curative intent), or metastatic UBC or locally advanced (unresectable and not treatable with curative intent) or metastatic pancreatic cancer/cholangiocarcinoma
There must be no standard treatment options available for participants with the above HER2 overexpressing tumors and they must have undergone at least one prior platinum-based treatment for locally advanced (unresectable and not treatable with curative intent) or metastatic tumor (Note: for pancreatic cancer/cholangiocarcinoma, prior treatments are not required to be platinum-based.)
Participant's lesion should be measurable according to RECIST V1.1 on diagnostic computed tomography (CT) scan/magnetic resonance imaging (MRI); Target lesion(s) should not have been previously irradiated
At least one formalin-fixed paraffin-embedded (FFPE) biopsy of the primary tumor and/or from a metastatic site is required
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
No significant cardiac history and a current left ventricular ejection fraction (LVEF) \>/=50%
Adequate organ function
Life expectancy of at least 12 weeks
You may not be if
Participants with previous exposure to HER2-targeted therapies in any setting
Participants showing histologically confirmed focal HER2-expression, that is, less than (\<) 30% of positively stained tumor cells
Participants with brain metastasis as the sole site of metastatic disease and/or are symptomatic or require therapy to control symptoms
Current uncontrolled hypertension (systolic greater than \[\>\] 150 millimeters of mercury \[mmHg\] and/or diastolic \>100 mmHg)
Current unstable angina pectoris
History of symptomatic congestive heart failure (CHF) of any New York Heart Association (NYHA) criteria or ventricular arrhythmia that requires treatment
History of myocardial infarction within the last 6 months
Peripheral neuropathy, Grade \>/=3
Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
Current severe, uncontrolled systemic disease
History of other malignancy within the last 5 years
Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C
Known prior severe hypersensitivity to trastuzumab and trastuzumab emtansine or the excipients of the investigational medicinal product (IMP)
Clinically significant bleeding within 30 days before enrollment
Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
Concurrent participation in any other therapeutic clinical trial
Clareo Health | A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors
