Breast Cancer
Conditions
Brief summary
This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.
Interventions
DRUGTrastuzumab
Trastuzumab will be administered at a dose of 6 milligrams per kilogram (mg/kg) IV or 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score | Baseline up to 6 cycles (cycle length = 21 days) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events | approximately 4 years |
| Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score | Baseline up to 6 cycles (cycle length = 21 days) |
Countries
France
Outcome results
None listed