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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
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.
Clinique Du Docteur Calabet; Cromg
Agen, France
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, France
ICO Paul Papin; Oncologie Medicale.
Angers, France
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, France
Institut Sainte-Catherine; Oncologie
Avignon, France
Centre Hospitalier de La Cote Basque; Oncologie
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)
Percentage of Participants With Adverse Events
Time frame: approximately 4 years
Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score
Time frame: Baseline up to 6 cycles (cycle length = 21 days)
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Bayonne, France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, France
Institut Bergonie
Bordeaux, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg-en-Bresse, France
Hopital Morvan
Brest, France
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