An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT02286362
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 510
- Aged >/= 18 years
- Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment
- Patients for whom the investigator has decided to start a treatment with Herceptin SC
- Trastuzumab treatment naive or non-naive (previously intravenous treatment)
- Informed consent
- Patients previously treated with Herceptin SC treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (composite outcome measure): Incidence, nature, and severity according to NCI-CTCAE v. 4.0 of: adverse events (AEs), serious AEs, grade >/= 3 AEs, non-serious adverse drug reaction or causality unknown, AESI (congestive heart failure) approximately 13 months
- Secondary Outcome Measures
Name Time Method Number of modalities regarding dose and injection site of Herceptin SC administration Up to 12 months Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire Every 3 months, up to 12 months Demographic data Up to 12 months
Trial Locations
- Locations (97)
CROM
🇫🇷Osny, France
C H Du Pays D'Aix En Provence; Hopital De Jour
🇫🇷Aix En Provence, France
Clinique Du Docteur Calabet; Cromg
🇫🇷Agen, France
Ch Du Pays D Aix; Maternite Gynecologie
🇫🇷Aix En Provence, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
🇫🇷Aix En Provence, France
Centre Hospitalier Albi; Oncologie
🇫🇷Albi, France
Hopital Prive D Antony; Oncologie
🇫🇷Antony, France
Cmc De Tronquieres;Chimiotherapie Et Radiotherapie
🇫🇷Aurillac, France
Clinique Claude Bernard; Onco Hematologie
🇫🇷Albi, France
Ch D Auxerre; Oncologie
🇫🇷Auxerre, France
Centre Oncologie Du Pays Basque
🇫🇷Bayonne, France
Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie
🇫🇷Bastia, France
Hopital De Falconaja Furiani; Hopital De Jour
🇫🇷Bastia, France
HOPITAL JEAN MINJOZ; Oncologie
🇫🇷Besancon, France
Centre Pierre Curie
🇫🇷Beuvry, France
Hopital Avicenne; Cancerologie
🇫🇷Bobigny, France
Ch De Beziers; Hematologie
🇫🇷Beziers, France
Clinique Tivoli; Chimiotherapie Radiotherapie
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
🇫🇷Bordeaux, France
Hopital Augustin Morvan; Federation De Cancerologie
🇫🇷Brest, France
Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
🇫🇷Brest, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
🇫🇷Bourg En Bresse, France
Hopital Pierre Nouveau; Medecine A
🇫🇷Cannes, France
CH Carcassonne; Service Onco Hematologie
🇫🇷Carcassonne, France
Clinique Montreal; Chimiotherapie
🇫🇷Carcassonne, France
Medipole De Savoie; Departement Oncologie
🇫🇷Challes Les Eaux, France
Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire
🇫🇷Champigny Sur Marne, France
Centre De Radiotherapie Et D'Oncologie; Oncologie
🇫🇷Compiegne, France
Hopital Antoine Beclere; Hopital De Jour
🇫🇷Clamart Cedex, France
Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie
🇫🇷Creil Cedex 1, France
CH de Cholet; oncologie
🇫🇷Cholet, France
Chi De Creteil; Radiotherapie Oncologie
🇫🇷Creteil, France
Hopital Henri Mondor; Oncologie Medicale
🇫🇷Creteil, France
Centre Leonard De Vinci;Chimiotherapie
🇫🇷Dechy, France
Centre De Radiotherapie Du Parc
🇫🇷Dijon, France
Ch De La Dracenie; Hopital De Jour
🇫🇷Draguignan, France
Chi Emile Durkheim Site Epinal; Oncologie
🇫🇷Epinal, France
Clinique Claude Bernard; Chimiotherapie
🇫🇷Ermont, France
Chi De Frejus Saint Raphael; Oncologie
🇫🇷Frejus, France
Hopital Louis Pasteur; Oncologie Hematologie
🇫🇷Le Coudray, France
Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
🇫🇷GAP, France
Hopital Albert Michallon; Oncologie
🇫🇷La Tronche, France
Centre Mistral; Chirurgie Cancerologie Gynecologiques
🇫🇷Guilherand Granges, France
CH de Marne la vallee; Oncologie Medicale
🇫🇷Jossigny, France
Ch Du Mans; Medecine Hematologie Oncologie
🇫🇷Le Mans, France
Clinique Chenieux; Oncology
🇫🇷Limoges, France
Polyclinique Du Bois; Oncologie
🇫🇷Lille, France
Ch De Lons Le Saunier; Medecine 5
🇫🇷Lons Le Saunier, France
Ch De Longjumeau; Hopital De Jour Et Semaine
🇫🇷Longjumeau, France
Ch Bretagne Sud Site Scorff; Oncologie Medicale
🇫🇷Lorient, France
Clinique De La Sauvegarde; Chimiotherapie
🇫🇷Lyon, France
Clinique Saint Faron; Sce Oncologie Radiotherapie
🇫🇷Mareuil Les Meaux, France
Hopital Clinique Claude Bernard; Oncologie Medicale
🇫🇷Metz, France
Hopital Layne; Medecine Ambulatoire
🇫🇷Mont-de-marsan, France
Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie
🇫🇷Marseille, France
Ghi Le Raincy Montfermeil; Oncologie Medicale
🇫🇷Montfermeil, France
Ch De Montlucon; Hematologie Cancerologie
🇫🇷Montlucon, France
Clinique Clementville; Hopital De Jour
🇫🇷Montpellier, France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
🇫🇷Nancy, France
Centre Catherine de Sienne; Chimiotherapie
🇫🇷Nantes, France
Polyclinique Du Languedoc; Chimiotherapie
🇫🇷Narbonne, France
Hopital Caremeau; Maternite Gynecologie
🇫🇷Nimes Cedex 9, France
Hopital Caremeau; Hematologie Oncologie
🇫🇷Nimes, France
Clinique Valdegour
🇫🇷Nimes, France
Ch Georges Renon; Oncologie Radiotherapie
🇫🇷Niort, France
Ch Pitie Salpetriere; Oncologie Medicale
🇫🇷Paris, France
Ch Francois Mitterrand; Medecine Oncologie
🇫🇷Pau, France
Polyclinique Francheville; Med Chimiotherapie Radiotherapie
🇫🇷Perigueux, France
Centre Catalan D' Oncologie
🇫🇷Perpignan, France
CH Rene Dubos; Oncologie
🇫🇷Pontoise, France
Hopital Saint Jean; Centre Henri Pujol
🇫🇷Perpignan, France
CH Annecy Genevois site Annecy; Oncologie
🇫🇷Pringy, France
Chi De Cornouaille; Oncologie Hospitalisation
🇫🇷Quimper, France
Institut Jean Godinot; Pavillon Rubis
🇫🇷Reims, France
Clinique de la Theuillerie; Oncologie
🇫🇷Ris Orangis, France
Clinique Armoricaine Radiologie; Cons Externes
🇫🇷Saint Brieuc, France
Clinique Francois 1er; Service De Chimiotherapie
🇫🇷Saint Dizier, France
Chp Saint Gregoire; Cancerologie Radiotherapie
🇫🇷Saint Gregoire, France
Clinique de L'Union; Oncologie
🇫🇷Saint Jean, France
Clinique Mutualiste L Estuaire
🇫🇷Saint Nazaire, France
Ch Gaston Ramon; Hopital De Jour
🇫🇷Sens, France
Centre Clinical; Oncologie Medicale
🇫🇷Soyaux, France
CH de Saint Jean De Maurienne; Had St Jean De Maurienne
🇫🇷St Jean De Maurienne Cedex, France
Clinique De L Estree; Oncologie Medicale
🇫🇷Stains, France
Centre Hospitalier De Sens; Medecine Generale Oncologie
🇫🇷Sens Cedex, France
Clinique Medico Chir Charcot; Chir Cancerologie
🇫🇷Ste Foy Les Lyon, France
Institut D Oncologie Medical
🇫🇷Strasbourg, France
Strasbourg Oncologie Libérale
🇫🇷Strasbourg, France
Hopital Civil; Hematologie Oncologie
🇫🇷Strasbourg, France
Hopitaux Du Leman Site Thonon; Maternite Gynecologie
🇫🇷Thonon Les Bains, France
Clinique Pasteur; Oncologie Medicale
🇫🇷Toulouse, France
Clinique Saint Jean Languedoc; Oncologie Medicale
🇫🇷Toulouse, France
Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
🇫🇷Tours, France
Centre Alexis Vautrin; Oncologie Medicale
🇫🇷Vandoeuvre Les Nancy, France
Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie
🇫🇷Villeneuve D Ascq, France
CMC de Bligny; Oncologie Court Sejour
🇫🇷Briis Sous Forges, France
GH Paris Saint Joseph; Hopital De Jour Oncologie
🇫🇷Paris, France