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
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
For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception; contraception use should continue for the duration of the study treatment and for at least 6 months after the last dose of study treatment
You may not be if
History of treatment with trastuzumab emtansine
Prior treatment with lapatinib or capecitabine
Peripheral neuropathy of Grade \>/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0
History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above
History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria
History of radiation therapy within 14 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 within 6 months of randomization
Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
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), hepatitis B virus, or hepatitis C virus
Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab
Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency
Current treatment with sorivudine or its chemically related analogs, such as brivudine
Clareo Health | A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
