Clinical trial NCT02286362: An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-11-07
Enrollment: 510
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HER2-positive early breast cancer scheduled to initiate a treatment with Herceptin SC.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: approximately 13 months
Secondary outcomes:
measure: Demographic data
timeFrame: Up to 12 months
measure: Number of modalities regarding dose and injection site of Herceptin SC administration
timeFrame: Up to 12 months
measure: Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire
timeFrame: Every 3 months, up to 12 months
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Du Docteur Calabet; Cromg
city: Aix En Provence
country: France
facility: C H Du Pays D'Aix En Provence; Hopital De Jour
city: Aix En Provence
country: France
facility: Ch Du Pays D Aix; Maternite Gynecologie
city: Aix En Provence
country: France
facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
city: Albi
country: France
facility: Centre Hospitalier Albi; Oncologie
city: Albi
country: France
facility: Clinique Claude Bernard; Onco Hematologie
city: Antony
country: France
facility: Hopital Prive D Antony; Oncologie
city: Aurillac
country: France
facility: Cmc De Tronquieres;Chimiotherapie Et Radiotherapie
city: Auxerre
country: France
facility: Ch D Auxerre; Oncologie
city: Bastia
country: France
facility: Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie
city: Bastia
country: France
facility: Hopital De Falconaja Furiani; Hopital De Jour
city: Bayonne
country: France
facility: Centre Oncologie Du Pays Basque
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Beuvry
country: France
facility: Centre Pierre Curie
city: Beziers
country: France
facility: Ch De Beziers; Hematologie
city: Bobigny
country: France
facility: Hopital Avicenne; Cancerologie
city: Bordeaux
country: France
facility: Clinique Tivoli; Chimiotherapie Radiotherapie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
city: Bourg En Bresse
country: France
facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie
city: Brest
country: France
facility: Hopital Augustin Morvan; Federation De Cancerologie
city: Brest
country: France
facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
city: Briis Sous Forges
country: France
facility: CMC de Bligny; Oncologie Court Sejour
city: Cannes
country: France
facility: Hopital Pierre Nouveau; Medecine A
city: Carcassonne
country: France
facility: CH Carcassonne; Service Onco Hematologie
city: Carcassonne
country: France
facility: Clinique Montreal; Chimiotherapie
city: Challes Les Eaux
country: France
facility: Medipole De Savoie; Departement Oncologie
city: Champigny Sur Marne
country: France
facility: Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire
city: Cholet
country: France
facility: CH de Cholet; oncologie
city: Clamart Cedex
country: France
facility: Hopital Antoine Beclere; Hopital De Jour
city: Compiegne
country: France
facility: Centre De Radiotherapie Et D'Oncologie; Oncologie
city: Creil Cedex 1
country: France
facility: Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie
city: Creteil
country: France
facility: Chi De Creteil; Radiotherapie Oncologie
city: Creteil
country: France
facility: Hopital Henri Mondor; Oncologie Medicale
city: Dechy
country: France
facility: Centre Leonard De Vinci;Chimiotherapie
city: Dijon
country: France
facility: Centre De Radiotherapie Du Parc
city: Draguignan
country: France
facility: Ch De La Dracenie; Hopital De Jour
city: Epinal
country: France
facility: Chi Emile Durkheim Site Epinal; Oncologie
city: Ermont
country: France
facility: Clinique Claude Bernard; Chimiotherapie
city: Frejus
country: France
facility: Chi De Frejus Saint Raphael; Oncologie
city: GAP
country: France
facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
city: Guilherand Granges
country: France
facility: Centre Mistral; Chirurgie Cancerologie Gynecologiques
city: Jossigny
country: France
facility: CH de Marne la vallee; Oncologie Medicale
city: La Tronche
country: France
facility: Hopital Albert Michallon; Oncologie
city: Le Coudray
country: France
facility: Hopital Louis Pasteur; Oncologie Hematologie
city: Le Mans
country: France
facility: Ch Du Mans; Medecine Hematologie Oncologie
city: Lille
country: France
facility: Polyclinique Du Bois; Oncologie
city: Limoges
country: France
facility: Clinique Chenieux; Oncology
city: Longjumeau
country: France
facility: Ch De Longjumeau; Hopital De Jour Et Semaine
city: Lons Le Saunier
country: France
facility: Ch De Lons Le Saunier; Medecine 5
city: Lorient
country: France
facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale
city: Lyon
country: France
facility: Clinique De La Sauvegarde; Chimiotherapie
city: Mareuil Les Meaux
country: France
facility: Clinique Saint Faron; Sce Oncologie Radiotherapie
city: Marseille
country: France
facility: Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie
city: Metz
country: France
facility: Hopital Clinique Claude Bernard; Oncologie Medicale
city: Mont-de-marsan
country: France
facility: Hopital Layne; Medecine Ambulatoire
city: Montfermeil
country: France
facility: Ghi Le Raincy Montfermeil; Oncologie Medicale
city: Montlucon
country: France
facility: Ch De Montlucon; Hematologie Cancerologie
city: Montpellier
country: France
facility: Clinique Clementville; Hopital De Jour
city: Nancy
country: France
facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
city: Nantes
country: France
facility: Centre Catherine de Sienne; Chimiotherapie
city: Narbonne
country: France
facility: Polyclinique Du Languedoc; Chimiotherapie
city: Nimes Cedex 9
country: France
facility: Hopital Caremeau; Maternite Gynecologie
city: Nimes
country: France
facility: Hopital Caremeau; Hematologie Oncologie
city: Nimes
country: France
facility: Clinique Valdegour
city: Niort
country: France
facility: Ch Georges Renon; Oncologie Radiotherapie
city: Osny
country: France
facility: CROM
city: Paris
country: France
facility: Ch Pitie Salpetriere; Oncologie Medicale
city: Paris
country: France
facility: GH Paris Saint Joseph; Hopital De Jour Oncologie
city: Pau
country: France
facility: Ch Francois Mitterrand; Medecine Oncologie
city: Perigueux
country: France
facility: Polyclinique Francheville; Med Chimiotherapie Radiotherapie
city: Perpignan
country: France
facility: Centre Catalan D' Oncologie
city: Perpignan
country: France
facility: Hopital Saint Jean; Centre Henri Pujol
city: Pontoise
country: France
facility: CH Rene Dubos; Oncologie
city: Pringy
country: France
facility: CH Annecy Genevois site Annecy; Oncologie
city: Quimper
country: France
facility: Chi De Cornouaille; Oncologie Hospitalisation
city: Reims
country: France
facility: Institut Jean Godinot; Pavillon Rubis
city: Ris Orangis
country: France
facility: Clinique de la Theuillerie; Oncologie
city: Saint Brieuc
country: France
facility: Clinique Armoricaine Radiologie; Cons Externes
city: Saint Dizier
country: France
facility: Clinique Francois 1er; Service De Chimiotherapie
city: Saint Gregoire
country: France
facility: Chp Saint Gregoire; Cancerologie Radiotherapie
city: Saint Jean
country: France
facility: Clinique de L'Union; Oncologie
city: Saint Nazaire
country: France
facility: Clinique Mutualiste L Estuaire
city: Sens Cedex
country: France
facility: Centre Hospitalier De Sens; Medecine Generale Oncologie
city: Sens
country: France
facility: Ch Gaston Ramon; Hopital De Jour
city: Soyaux
country: France
facility: Centre Clinical; Oncologie Medicale
city: St Jean De Maurienne Cedex
country: France
facility: CH de Saint Jean De Maurienne; Had St Jean De Maurienne
city: Stains
country: France
facility: Clinique De L Estree; Oncologie Medicale
city: Ste Foy Les Lyon
country: France
facility: Clinique Medico Chir Charcot; Chir Cancerologie
city: Strasbourg
country: France
facility: Institut D Oncologie Medical
city: Strasbourg
country: France
facility: Strasbourg Oncologie Libérale
city: Strasbourg
country: France
facility: Hopital Civil; Hematologie Oncologie
city: Thonon Les Bains
country: France
facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie
city: Toulouse
country: France
facility: Clinique Pasteur; Oncologie Medicale
city: Toulouse
country: France
facility: Clinique Saint Jean Languedoc; Oncologie Medicale
city: Tours
country: France
facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Villeneuve D Ascq
country: France
facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: