Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2019
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01810393
Start Date
June 11 2013
End Date
July 17 2019
Last Update
September 4 2020
Active Locations (61)
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1
Clinique Du Docteur Calabet; Cromg
Agen, France, 47000
2
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, France, 80090
3
ICO Paul Papin; Oncologie Medicale.
Angers, France, 49055
4
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, France, 62012