An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
1 other identifier
observational
510
1 country
97
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedStudy Start
First participant enrolled
January 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2016
CompletedSeptember 27, 2017
September 1, 2017
1.8 years
October 30, 2014
September 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Every 3 months, up to 12 months
Study Arms (1)
Cohort
Eligibility Criteria
Patients with HER2-positive early breast cancer scheduled to initiate a treatment with Herceptin SC.
You may qualify if:
- 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
You may not qualify if:
- Patients previously treated with Herceptin SC treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
Clinique Du Docteur Calabet; Cromg
Agen, 47000, France
C H Du Pays D'Aix En Provence; Hopital De Jour
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 7, 2014
Study Start
January 14, 2015
Primary Completion
November 10, 2016
Study Completion
November 10, 2016
Last Updated
September 27, 2017
Record last verified: 2017-09