An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer

NCT ID: NCT02286362

Last Updated: 2017-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

510 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-14

Study Completion Date

2016-11-10

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Clinique Du Docteur Calabet; Cromg

Agen, , France

Site Status

C H Du Pays D'Aix En Provence; Hopital De Jour

Aix-en-Provence, , France

Site Status

Ch Du Pays D Aix; Maternite Gynecologie

Aix-en-Provence, , France

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Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

Aix-en-Provence, , France

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Centre Hospitalier Albi; Oncologie

Albi, , France

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Clinique Claude Bernard; Onco Hematologie

Albi, , France

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Hopital Prive D Antony; Oncologie

Antony, , France

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Cmc De Tronquieres;Chimiotherapie Et Radiotherapie

Aurillac, , France

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Ch D Auxerre; Oncologie

Auxerre, , France

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Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

Bastia, , France

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Hopital De Falconaja Furiani; Hopital De Jour

Bastia, , France

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Centre Oncologie Du Pays Basque

Bayonne, , France

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HOPITAL JEAN MINJOZ; Oncologie

Besançon, , France

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Centre Pierre Curie

Beuvry, , France

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Ch De Beziers; Hematologie

Béziers, , France

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Hopital Avicenne; Cancerologie

Bobigny, , France

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Clinique Tivoli; Chimiotherapie Radiotherapie

Bordeaux, , France

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Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

Bordeaux, , France

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Centre Hospitalier Fleyriat; Oncologie/Hematologie

Bourg-en-Bresse, , France

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Hopital Augustin Morvan; Federation De Cancerologie

Brest, , France

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Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

Brest, , France

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CMC de Bligny; Oncologie Court Sejour

Briis-sous-Forges, , France

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Hopital Pierre Nouveau; Medecine A

Cannes, , France

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CH Carcassonne; Service Onco Hematologie

Carcassonne, , France

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Clinique Montreal; Chimiotherapie

Carcassonne, , France

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Medipole De Savoie; Departement Oncologie

Challes-les-Eaux, , France

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Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

Champigny-sur-Marne, , France

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CH de Cholet; oncologie

Cholet, , France

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Hopital Antoine Beclere; Hopital De Jour

Clamart, , France

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Centre De Radiotherapie Et D'Oncologie; Oncologie

Compiègne, , France

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Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie

Creil, , France

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Chi De Creteil; Radiotherapie Oncologie

Créteil, , France

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Hopital Henri Mondor; Oncologie Medicale

Créteil, , France

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Centre Leonard De Vinci;Chimiotherapie

Dechy, , France

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Centre De Radiotherapie Du Parc

Dijon, , France

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Ch De La Dracenie; Hopital De Jour

Draguignan, , France

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Clinique Claude Bernard; Chimiotherapie

Ermont, , France

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Chi Emile Durkheim Site Epinal; Oncologie

Épinal, , France

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Chi De Frejus Saint Raphael; Oncologie

Fréjus, , France

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Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

Gap, , France

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Centre Mistral; Chirurgie Cancerologie Gynecologiques

Guilherand-Granges, , France

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CH de Marne la vallee; Oncologie Medicale

Jossigny, , France

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Hopital Albert Michallon; Oncologie

La Tronche, , France

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Hopital Louis Pasteur; Oncologie Hematologie

Le Coudray, , France

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Ch Du Mans; Medecine Hematologie Oncologie

Le Mans, , France

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Polyclinique Du Bois; Oncologie

Lille, , France

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Clinique Chenieux; Oncology

Limoges, , France

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Ch De Longjumeau; Hopital De Jour Et Semaine

Longjumeau, , France

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Ch De Lons Le Saunier; Medecine 5

Lons-le-Saunier, , France

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Ch Bretagne Sud Site Scorff; Oncologie Medicale

Lorient, , France

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Clinique De La Sauvegarde; Chimiotherapie

Lyon, , France

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Clinique Saint Faron; Sce Oncologie Radiotherapie

Mareuil-lès-Meaux, , France

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Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie

Marseille, , France

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Hopital Clinique Claude Bernard; Oncologie Medicale

Metz, , France

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Hopital Layne; Medecine Ambulatoire

Mont-de-Marsan, , France

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Ghi Le Raincy Montfermeil; Oncologie Medicale

Montfermeil, , France

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Ch De Montlucon; Hematologie Cancerologie

Montluçon, , France

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Clinique Clementville; Hopital De Jour

Montpellier, , France

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Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

Nancy, , France

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Centre Catherine de Sienne; Chimiotherapie

Nantes, , France

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Polyclinique Du Languedoc; Chimiotherapie

Narbonne, , France

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Ch Georges Renon; Oncologie Radiotherapie

Niort, , France

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Hopital Caremeau; Hematologie Oncologie

Nîmes, , France

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Hopital Caremeau; Maternite Gynecologie

Nîmes, , France

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Clinique Valdegour

Nîmes, , France

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CROM

Osny, , France

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Ch Pitie Salpetriere; Oncologie Medicale

Paris, , France

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GH Paris Saint Joseph; Hopital De Jour Oncologie

Paris, , France

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Ch Francois Mitterrand; Medecine Oncologie

Pau, , France

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Centre Catalan D' Oncologie

Perpignan, , France

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Hopital Saint Jean; Centre Henri Pujol

Perpignan, , France

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Polyclinique Francheville; Med Chimiotherapie Radiotherapie

Périgueux, , France

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CH Rene Dubos; Oncologie

Pontoise, , France

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CH Annecy Genevois site Annecy; Oncologie

Pringy, , France

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Chi De Cornouaille; Oncologie Hospitalisation

Quimper, , France

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Institut Jean Godinot; Pavillon Rubis

Reims, , France

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Clinique de la Theuillerie; Oncologie

Ris-Orangis, , France

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Clinique Armoricaine Radiologie; Cons Externes

Saint-Brieuc, , France

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Clinique Francois 1er; Service De Chimiotherapie

Saint-Dizier, , France

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Chp Saint Gregoire; Cancerologie Radiotherapie

Saint-Grégoire, , France

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Clinique de L'Union; Oncologie

Saint-Jean, , France

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CH de Saint Jean De Maurienne; Had St Jean De Maurienne

Saint-Jean-de-Maurienne, , France

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Clinique Mutualiste L Estuaire

Saint-Nazaire, , France

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Centre Hospitalier De Sens; Medecine Generale Oncologie

Sens, , France

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Ch Gaston Ramon; Hopital De Jour

Sens, , France

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Centre Clinical; Oncologie Medicale

Soyaux, , France

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Clinique De L Estree; Oncologie Medicale

Stains, , France

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Clinique Medico Chir Charcot; Chir Cancerologie

Ste Foy Les Lyon, , France

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Institut D Oncologie Medical

Strasbourg, , France

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Strasbourg Oncologie Libérale

Strasbourg, , France

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Hopital Civil; Hematologie Oncologie

Strasbourg, , France

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Hopitaux Du Leman Site Thonon; Maternite Gynecologie

Thonon-les-Bains, , France

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Clinique Pasteur; Oncologie Medicale

Toulouse, , France

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Clinique Saint Jean Languedoc; Oncologie Medicale

Toulouse, , France

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Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

Tours, , France

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Centre Alexis Vautrin; Oncologie Medicale

Vandœuvre-lès-Nancy, , France

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Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

Villeneuve-d'Ascq, , France

Site Status

Countries

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France

Other Identifiers

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ML28983

Identifier Type: -

Identifier Source: org_study_id