A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years
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 or cytologically confirmed HER2-positive metastatic breast cancer
On treatment with first-line trastuzumab IV and free of disease progression for at least 3 years
Left ventricular ejection fraction (LVEF) of greater than or equal to (\>/=) 50 percent (%)
Hormonal therapy will be allowed
Prior use of anti-HER2 therapy will be allowed
You may not be if
History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for at least 5 years; participants with previous ductal carcinoma in situ of the breast are also eligible
Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
Hepatitis B, hepatitis C or human immunodeficiency virus infection
Pregnant or lactating women
Concurrent enrollment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, for example, difficult to control asthma
Central nervous system metastases, unless they have been treated and have been stable for at least 3 years
Inadequate organ function
Clareo Health | A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years
