An Open-Label, Randomized, Multicenter Phase III Study in Patients With HER2-Positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab
Overview
- Phase
- Phase 3
- Intervention
- Trastuzumab
- Conditions
- Breast Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 114
- Locations
- 61
- Primary Endpoint
- Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Trastuzumab IV Then Trastuzumab SC
Participants will receive treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.
Intervention: Trastuzumab
Trastuzumab SC Then Trastuzumab IV
Participants will receive treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.
Intervention: Trastuzumab
Outcomes
Primary Outcomes
Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score
Time Frame: Baseline up to 6 cycles (cycle length = 21 days)
Secondary Outcomes
- 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))