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
- Registration Number
- NCT01810393
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Trastuzumab IV Then Trastuzumab SC Trastuzumab 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. Trastuzumab SC Then Trastuzumab IV Trastuzumab 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (61)
Clinique Du Docteur Calabet; Cromg
🇫🇷Agen, France
Clinique De L Europe; Radiotherapie Chimiotherapie
🇫🇷Amiens, France
HOP Prive Arras Les Bonnettes; Chimiotherapie
🇫🇷Arras, France
Polyclinique Du Bois; Oncologie
🇫🇷Lille, France
Clinique Victor Hugo; Radiotherapie
🇫🇷Le Mans, France
Institut Jean Godinot; Oncologie Medicale
🇫🇷Reims CEDEX, France
Clinique Mutualiste L Estuaire
🇫🇷Saint Nazaire, France
Institut de Cancérologie de Loire
🇫🇷St-Priest-En-Jarez, France
Hopital de Hautepierre
🇫🇷Strasbourg, France
Pole Sante Republique;Oncologie Hematologie
🇫🇷Clermont Ferrand, France
Chi De Creteil; Radiotherapie Oncologie
🇫🇷Creteil, France
Centre Leonard De Vinci;Chimiotherapie
🇫🇷Dechy, France
Centre Georges Francois Leclerc; Oncologie 3
🇫🇷Dijon, France
CHD Les Oudairies
🇫🇷La Roche Sur Yon, France
Ch Louis Pasteur; Oncologie
🇫🇷Le Coudray, France
Centre Oscar Lambret; Unite de Recherche Clinique
🇫🇷Lille, France
Ch Bretagne Sud Site Scorff; Oncologie Medicale
🇫🇷Lorient, France
Hopital Belle Isle; Oncologie Hematologie
🇫🇷Metz, France
Hopital Prive Jean Mermoz
🇫🇷Lyon, France
APHP - Hopital de la Pitie Salpetriere
🇫🇷Paris, France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
🇫🇷Nancy, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut de cancerologie du Gard
🇫🇷Nimes, France
Institut Curie; Oncologie Medicale
🇫🇷Paris, France
Hopital Saint Louis; Oncologie Medicale
🇫🇷Paris, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers cedex, France
Institut du Cancer Coulancy Reims
🇫🇷Reims, France
HOPITAL TENON; Cancerologie Medicale
🇫🇷Paris, France
Centre Eugene Marquis; Bureau D Etudes Cliniques
🇫🇷Rennes, France
Centre Henri Becquerel; Oncologie Medicale
🇫🇷Rouen, France
Chp Saint Gregoire; Cancerologie Radiotherapie
🇫🇷Saint Gregoire, France
Centre Rene Gauducheau
🇫🇷Saint Herblain, France
Hopital Prive Nord Parisien; Soins De Suite - Oncologie
🇫🇷Sarcelles, France
CMCO De La Cote D Opale; Auberge De Jour
🇫🇷St Martin Boulogne, France
Clinique Ste Anne
🇫🇷Strasbourg, France
HOPITAL JEAN MINJOZ; Oncologie
🇫🇷Besancon, France
Hopital Morvan
🇫🇷Brest, France
Hopital de Mercy ;ONCOLOGIE MEDICALE
🇫🇷Melz, France
Clinique De La Sauvegarde; Chimiotherapie
🇫🇷Lyon, France
ICO Paul Papin; Oncologie Medicale.
🇫🇷Angers, France
Institut Sainte-Catherine; Oncologie
🇫🇷Avignon, France
Centre Hospitalier de La Cote Basque; Oncologie
🇫🇷Bayonne, France
Centre Leon Berard
🇫🇷Lyon, France
Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
🇫🇷Brest, France
Institut Paoli Calmettes; Oncologie Medicale
🇫🇷Marseille, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
🇫🇷Bourg En Bresse, France
Institut Bergonie
🇫🇷Bordeaux, France
Centre Francois Baclesse; Oncologie
🇫🇷Caen, France
Centre Jean Perrin; Oncologie
🇫🇷Clermont Ferrand, France
Clinique Clementville; Hopital De Jour
🇫🇷Montpellier, France
Centre Catherine de Sienne; Chimiotherapie
🇫🇷Nantes, France
HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune
🇫🇷Orleans, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
CH d'Annecy
🇫🇷Pringy, France
Chi De Cornouaille; Oncologie Hospitalisation
🇫🇷Quimper, France
Polyclinique de la Cote Basque Sud; Oncologie
🇫🇷Saint Jean de Luz, France
CH de Saint Quentin
🇫🇷Saint Quentin, France
Hôpital Rangueil - CHU de Toulouse
🇫🇷Toulouse, France
Centre Paul Strauss; Oncologie Medicale
🇫🇷Strasbourg, France
Clinique Pasteur; Oncologie Medicale
🇫🇷Toulouse, France
Groupe Hospitalier Diaconesses
🇫🇷Paris, France