Breast Cancer Clinical Trial
| Verified date | September 2017 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 510 |
| Est. completion date | November 10, 2016 |
| Est. primary completion date | November 10, 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Patients previously treated with Herceptin SC treatment |
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique Du Docteur Calabet; Cromg | Agen | |
| France | C H Du Pays D'Aix En Provence; Hopital De Jour | Aix En Provence | |
| 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 | Clinique Claude Bernard; Onco Hematologie | Albi | |
| France | Hopital Prive D Antony; Oncologie | Antony | |
| France | Cmc De Tronquieres;Chimiotherapie Et Radiotherapie | Aurillac | |
| France | Ch D Auxerre; Oncologie | Auxerre | |
| France | Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie | Bastia | |
| France | Hopital De Falconaja Furiani; Hopital De Jour | Bastia | |
| France | Centre Oncologie Du Pays Basque | Bayonne | |
| France | HOPITAL JEAN MINJOZ; Oncologie | Besancon | |
| France | Centre Pierre Curie | Beuvry | |
| France | Ch De Beziers; Hematologie | Beziers | |
| France | Hopital Avicenne; Cancerologie | Bobigny | |
| France | Clinique Tivoli; Chimiotherapie Radiotherapie | Bordeaux | |
| France | Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | |
| France | Centre Hospitalier Fleyriat; Oncologie/Hematologie | Bourg En Bresse | |
| France | Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie | Brest | |
| France | Hopital Augustin Morvan; Federation De Cancerologie | Brest | |
| France | CMC de Bligny; Oncologie Court Sejour | Briis Sous Forges | |
| 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 | CH de Cholet; oncologie | Cholet | |
| France | Hopital Antoine Beclere; Hopital De Jour | Clamart Cedex | |
| France | Centre De Radiotherapie Et D'Oncologie; Oncologie | Compiegne | |
| France | Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie | Creil Cedex 1 | |
| 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 | Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente | GAP | |
| France | Centre Mistral; Chirurgie Cancerologie Gynecologiques | Guilherand Granges | |
| France | CH de Marne la vallee; Oncologie Medicale | Jossigny | |
| France | Hopital Albert Michallon; Oncologie | La Tronche | |
| France | Hopital Louis Pasteur; Oncologie Hematologie | Le Coudray | |
| France | Ch Du Mans; Medecine Hematologie Oncologie | Le Mans | |
| France | Polyclinique Du Bois; Oncologie | Lille | |
| France | Clinique Chenieux; Oncology | Limoges | |
| France | Ch De Longjumeau; Hopital De Jour Et Semaine | Longjumeau | |
| France | Ch De Lons Le Saunier; Medecine 5 | Lons Le Saunier | |
| 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 | Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie | Marseille | |
| France | Hopital Clinique Claude Bernard; Oncologie Medicale | Metz | |
| France | Hopital Layne; Medecine Ambulatoire | Mont-de-marsan | |
| 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 | Clinique Valdegour | Nimes | |
| France | Hopital Caremeau; Hematologie Oncologie | Nimes | |
| France | Hopital Caremeau; Maternite Gynecologie | Nimes Cedex 9 | |
| France | Ch Georges Renon; Oncologie Radiotherapie | Niort | |
| France | CROM | Osny | |
| France | Ch Pitie Salpetriere; Oncologie Medicale | Paris | |
| France | GH Paris Saint Joseph; Hopital De Jour Oncologie | Paris | |
| France | Ch Francois Mitterrand; Medecine Oncologie | Pau | |
| France | Polyclinique Francheville; Med Chimiotherapie Radiotherapie | Perigueux | |
| France | Centre Catalan D' Oncologie | Perpignan | |
| France | Hopital Saint Jean; Centre Henri Pujol | Perpignan | |
| France | CH Rene Dubos; Oncologie | Pontoise | |
| 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 Hospitalier De Sens; Medecine Generale Oncologie | Sens Cedex | |
| 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 | Clinique Medico Chir Charcot; Chir Cancerologie | Ste Foy Les Lyon | |
| France | Hopital Civil; Hematologie Oncologie | Strasbourg | |
| France | Institut D Oncologie Medical | Strasbourg | |
| France | Strasbourg Oncologie Libérale | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Demographic data | Up to 12 months | ||
| Secondary | Number of modalities regarding dose and injection site of Herceptin SC administration | Up to 12 months | ||
| Secondary | Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire | Every 3 months, up to 12 months |
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