Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | Up to 12 months | |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with HER2-positive early breast cancer scheduled to initiate a treatment with Herceptin SC.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Du Docteur Calabet; Cromg | Agen | 47000 | France | |||
| C H Du Pays D'Aix En Provence; Hopital De Jour |
Not provided
Not provided
Not provided
Not provided
| Every 3 months, up to 12 months |
| Aix-en-Provence |
| 13616 |
| France |
| Ch Du Pays D Aix; Maternite Gynecologie | Aix-en-Provence | 13616 | France |
| Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire | Aix-en-Provence | 13617 | France |
| Centre Hospitalier Albi; Oncologie | Albi | 81000 | France |
| Clinique Claude Bernard; Onco Hematologie | Albi | 81030 | France |
| Hopital Prive D Antony; Oncologie | Antony | 92166 | France |
| Cmc De Tronquieres;Chimiotherapie Et Radiotherapie | Aurillac | 15013 | France |
| Ch D Auxerre; Oncologie | Auxerre | 89011 | France |
| Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie | Bastia | 20200 | France |
| Hopital De Falconaja Furiani; Hopital De Jour | Bastia | 20604 | France |
| Centre Oncologie Du Pays Basque | Bayonne | 64100 | France |
| HOPITAL JEAN MINJOZ; Oncologie | Besançon | 25030 | France |
| Centre Pierre Curie | Beuvry | 62660 | France |
| Ch De Beziers; Hematologie | Béziers | 34525 | France |
| Hopital Avicenne; Cancerologie | Bobigny | 93009 | France |
| Clinique Tivoli; Chimiotherapie Radiotherapie | Bordeaux | 33030 | France |
| Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | 33077 | France |
| Centre Hospitalier Fleyriat; Oncologie/Hematologie | Bourg-en-Bresse | 01012 | France |
| Hopital Augustin Morvan; Federation De Cancerologie | Brest | 29200 | France |
| Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie | Brest | 29220 | France |
| CMC de Bligny; Oncologie Court Sejour | Briis-sous-Forges | 91640 | France |
| Hopital Pierre Nouveau; Medecine A | Cannes | 06400 | France |
| CH Carcassonne; Service Onco Hematologie | Carcassonne | 11000 | France |
| Clinique Montreal; Chimiotherapie | Carcassonne | France |
| Medipole De Savoie; Departement Oncologie | Challes-les-Eaux | 73190 | France |
| Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire | Champigny-sur-Marne | 94507 | France |
| CH de Cholet; oncologie | Cholet | 49325 | France |
| Hopital Antoine Beclere; Hopital De Jour | Clamart | 92141 | France |
| Centre De Radiotherapie Et D'Oncologie; Oncologie | Compiègne | 60200 | France |
| Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie | Creil | 60109 | France |
| Chi De Creteil; Radiotherapie Oncologie | Créteil | 94010 | France |
| Hopital Henri Mondor; Oncologie Medicale | Créteil | 94010 | France |
| Centre Leonard De Vinci;Chimiotherapie | Dechy | 59187 | France |
| Centre De Radiotherapie Du Parc | Dijon | 21000 | France |
| Ch De La Dracenie; Hopital De Jour | Draguignan | 83007 | France |
| Clinique Claude Bernard; Chimiotherapie | Ermont | 95120 | France |
| Chi Emile Durkheim Site Epinal; Oncologie | Épinal | 88021 | France |
| Chi De Frejus Saint Raphael; Oncologie | Fréjus | 83608 | France |
| Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente | Gap | 05000 | France |
| Centre Mistral; Chirurgie Cancerologie Gynecologiques | Guilherand-Granges | 07500 | France |
| CH de Marne la vallee; Oncologie Medicale | Jossigny | 77600 | France |
| Hopital Albert Michallon; Oncologie | La Tronche | 38700 | France |
| Hopital Louis Pasteur; Oncologie Hematologie | Le Coudray | 28630 | France |
| Ch Du Mans; Medecine Hematologie Oncologie | Le Mans | 72037 | France |
| Polyclinique Du Bois; Oncologie | Lille | 59003 | France |
| Clinique Chenieux; Oncology | Limoges | 87039 | France |
| Ch De Longjumeau; Hopital De Jour Et Semaine | Longjumeau | 91161 | France |
| Ch De Lons Le Saunier; Medecine 5 | Lons-le-Saunier | 39016 | France |
| Ch Bretagne Sud Site Scorff; Oncologie Medicale | Lorient | 56100 | France |
| Clinique De La Sauvegarde; Chimiotherapie | Lyon | 69337 | France |
| Clinique Saint Faron; Sce Oncologie Radiotherapie | Mareuil-lès-Meaux | 77100 | France |
| Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie | Marseille | 13004 | France |
| Hopital Clinique Claude Bernard; Oncologie Medicale | Metz | 57000 | France |
| Hopital Layne; Medecine Ambulatoire | Mont-de-Marsan | 40024 | France |
| Ghi Le Raincy Montfermeil; Oncologie Medicale | Montfermeil | 93370 | France |
| Ch De Montlucon; Hematologie Cancerologie | Montluçon | 03100 | France |
| Clinique Clementville; Hopital De Jour | Montpellier | 34070 | France |
| Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE | Nancy | 54100 | France |
| Centre Catherine de Sienne; Chimiotherapie | Nantes | 44202 | France |
| Polyclinique Du Languedoc; Chimiotherapie | Narbonne | 11780 | France |
| Ch Georges Renon; Oncologie Radiotherapie | Niort | 79021 | France |
| Hopital Caremeau; Hematologie Oncologie | Nîmes | 30029 | France |
| Hopital Caremeau; Maternite Gynecologie | Nîmes | 30029 | France |
| Clinique Valdegour | Nîmes | 30900 | France |
| CROM | Osny | 95520 | France |
| Ch Pitie Salpetriere; Oncologie Medicale | Paris | 75651 | France |
| GH Paris Saint Joseph; Hopital De Jour Oncologie | Paris | 75674 | France |
| Ch Francois Mitterrand; Medecine Oncologie | Pau | 64046 | France |
| Centre Catalan D' Oncologie | Perpignan | 66000 | France |
| Hopital Saint Jean; Centre Henri Pujol | Perpignan | 66046 | France |
| Polyclinique Francheville; Med Chimiotherapie Radiotherapie | Périgueux | 24000 | France |
| CH Rene Dubos; Oncologie | Pontoise | 95300 | France |
| CH Annecy Genevois site Annecy; Oncologie | Pringy | 74374 | France |
| Chi De Cornouaille; Oncologie Hospitalisation | Quimper | 29107 | France |
| Institut Jean Godinot; Pavillon Rubis | Reims | 51056 | France |
| Clinique de la Theuillerie; Oncologie | Ris-Orangis | 91130 | France |
| Clinique Armoricaine Radiologie; Cons Externes | Saint-Brieuc | 22015 | France |
| Clinique Francois 1er; Service De Chimiotherapie | Saint-Dizier | 52100 | France |
| Chp Saint Gregoire; Cancerologie Radiotherapie | Saint-Grégoire | 35768 | France |
| Clinique de L'Union; Oncologie | Saint-Jean | 31240 | France |
| CH de Saint Jean De Maurienne; Had St Jean De Maurienne | Saint-Jean-de-Maurienne | 73303 | France |
| Clinique Mutualiste L Estuaire | Saint-Nazaire | 44606 | France |
| Centre Hospitalier De Sens; Medecine Generale Oncologie | Sens | 89108 | France |
| Ch Gaston Ramon; Hopital De Jour | Sens | 89108 | France |
| Centre Clinical; Oncologie Medicale | Soyaux | 16800 | France |
| Clinique De L Estree; Oncologie Medicale | Stains | 93240 | France |
| Clinique Medico Chir Charcot; Chir Cancerologie | Ste Foy Les Lyon | 69110 | France |
| Institut D Oncologie Medical | Strasbourg | 67000 | France |
| Strasbourg Oncologie Libérale | Strasbourg | 67000 | France |
| Hopital Civil; Hematologie Oncologie | Strasbourg | 67091 | France |
| Hopitaux Du Leman Site Thonon; Maternite Gynecologie | Thonon-les-Bains | 74203 | France |
| Clinique Pasteur; Oncologie Medicale | Toulouse | 31076 | France |
| Clinique Saint Jean Languedoc; Oncologie Medicale | Toulouse | 31077 | France |
| Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie | Tours | 37044 | France |
| Centre Alexis Vautrin; Oncologie Medicale | Vandœuvre-lès-Nancy | 54511 | France |
| Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie | Villeneuve-d'Ascq | 59657 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided