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

September 26, 2017 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47000
        • Clinique Du Docteur Calabet; Cromg
      • Aix En Provence, France, 13617
        • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
      • Aix En Provence, France, 13616
        • C H Du Pays D'Aix En Provence; Hopital De Jour
      • Aix En Provence, France, 13616
        • Ch Du Pays D Aix; Maternite Gynecologie
      • Albi, France, 81030
        • Clinique Claude Bernard; Onco Hematologie
      • Albi, France, 81000
        • Centre Hospitalier Albi; Oncologie
      • Antony, France, 92166
        • Hopital Prive D Antony; Oncologie
      • Aurillac, France, 15013
        • Cmc De Tronquieres;Chimiotherapie Et Radiotherapie
      • Auxerre, France, 89011
        • Ch D Auxerre; Oncologie
      • Bastia, France, 20200
        • Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie
      • Bastia, France, 20604
        • Hopital De Falconaja Furiani; Hopital De Jour
      • Bayonne, France, 64100
        • Centre Oncologie Du Pays Basque
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Beuvry, France, 62660
        • centre Pierre Curie
      • Beziers, France, 34525
        • Ch De Beziers; Hematologie
      • Bobigny, France, 93009
        • Hopital Avicenne; Cancerologie
      • Bordeaux, France, 33030
        • Clinique Tivoli; Chimiotherapie Radiotherapie
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
      • Bourg En Bresse, France, 01012
        • Centre Hospitalier Fleyriat; Oncologie/Hematologie
      • Brest, France, 29200
        • Hopital Augustin Morvan; Federation De Cancerologie
      • Brest, France, 29220
        • Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
      • Briis Sous Forges, France, 91640
        • CMC de Bligny; Oncologie Court Sejour
      • Cannes, France, 06400
        • Hopital Pierre Nouveau; Medecine A
      • Carcassonne, France
        • Clinique Montreal; Chimiotherapie
      • Carcassonne, France, 11000
        • CH Carcassonne; Service Onco Hematologie
      • Challes Les Eaux, France, 73190
        • Medipole De Savoie; Departement Oncologie
      • Champigny Sur Marne, France, 94507
        • Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire
      • Cholet, France, 49325
        • CH de Cholet; oncologie
      • Clamart Cedex, France, 92141
        • Hopital Antoine Beclere; Hopital De Jour
      • Compiegne, France, 60200
        • Centre De Radiotherapie Et D'Oncologie; Oncologie
      • Creil Cedex 1, France, 60109
        • Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie
      • Creteil, France, 94010
        • Chi De Creteil; Radiotherapie Oncologie
      • Creteil, France, 94010
        • Hopital Henri Mondor; Oncologie Medicale
      • Dechy, France, 59187
        • Centre Leonard De Vinci;Chimiotherapie
      • Dijon, France, 21000
        • Centre de Radiotherapie du Parc
      • Draguignan, France, 83007
        • Ch De La Dracenie; Hopital De Jour
      • Epinal, France, 88021
        • Chi Emile Durkheim Site Epinal; Oncologie
      • Ermont, France, 95120
        • Clinique Claude Bernard; Chimiotherapie
      • Frejus, France, 83608
        • Chi De Frejus Saint Raphael; Oncologie
      • GAP, France, 05000
        • Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
      • Guilherand Granges, France, 07500
        • Centre Mistral; Chirurgie Cancerologie Gynecologiques
      • Jossigny, France, 77600
        • CH de Marne la vallee; Oncologie Medicale
      • La Tronche, France, 38700
        • Hopital Albert Michallon; Oncologie
      • Le Coudray, France, 28630
        • Hopital Louis Pasteur; Oncologie Hematologie
      • Le Mans, France, 72037
        • Ch Du Mans; Medecine Hematologie Oncologie
      • Lille, France, 59003
        • Polyclinique Du Bois; Oncologie
      • Limoges, France, 87039
        • Clinique Chenieux; Oncology
      • Longjumeau, France, 91161
        • Ch De Longjumeau; Hopital De Jour Et Semaine
      • Lons Le Saunier, France, 39016
        • Ch De Lons Le Saunier; Medecine 5
      • Lorient, France, 56100
        • Ch Bretagne Sud Site Scorff; Oncologie Medicale
      • Lyon, France, 69337
        • Clinique De La Sauvegarde; Chimiotherapie
      • Mareuil Les Meaux, France, 77100
        • Clinique Saint Faron; Sce Oncologie Radiotherapie
      • Marseille, France, 13004
        • Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie
      • Metz, France, 57000
        • Hopital Clinique Claude Bernard; Oncologie Medicale
      • Mont-de-marsan, France, 40024
        • Hopital Layne; Medecine Ambulatoire
      • Montfermeil, France, 93370
        • Ghi Le Raincy Montfermeil; Oncologie Medicale
      • Montlucon, France, 03100
        • Ch De Montlucon; Hematologie Cancerologie
      • Montpellier, France, 34070
        • Clinique Clementville; Hopital De Jour
      • Nancy, France, 54100
        • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
      • Nantes, France, 44202
        • Centre Catherine de Sienne; Chimiotherapie
      • Narbonne, France, 11780
        • Polyclinique Du Languedoc; Chimiotherapie
      • Nimes, France, 30029
        • Hopital Caremeau; Hematologie Oncologie
      • Nimes, France, 30900
        • Clinique Valdegour
      • Nimes Cedex 9, France, 30029
        • Hopital Caremeau; Maternite Gynecologie
      • Niort, France, 79021
        • Ch Georges Renon; Oncologie Radiotherapie
      • Osny, France, 95520
        • CROM
      • Paris, France, 75674
        • GH Paris Saint Joseph; Hopital De Jour Oncologie
      • Paris, France, 75651
        • Ch Pitie Salpetriere; Oncologie Medicale
      • Pau, France, 64046
        • Ch Francois Mitterrand; Medecine Oncologie
      • Perigueux, France, 24000
        • Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
      • Perpignan, France, 66000
        • Centre Catalan D' Oncologie
      • Perpignan, France, 66046
        • Hopital Saint Jean; Centre Henri Pujol
      • Pontoise, France, 95300
        • CH Rene Dubos; Oncologie
      • Pringy, France, 74374
        • CH Annecy Genevois site Annecy; Oncologie
      • Quimper, France, 29107
        • Chi De Cornouaille; Oncologie Hospitalisation
      • Reims, France, 51056
        • Institut Jean Godinot; Pavillon Rubis
      • Ris Orangis, France, 91130
        • Clinique de la Theuillerie; Oncologie
      • Saint Brieuc, France, 22015
        • Clinique Armoricaine Radiologie; Cons Externes
      • Saint Dizier, France, 52100
        • Clinique Francois 1er; Service De Chimiotherapie
      • Saint Gregoire, France, 35768
        • Chp Saint Gregoire; Cancerologie Radiotherapie
      • Saint Jean, France, 31240
        • Clinique de L'Union; Oncologie
      • Saint Nazaire, France, 44606
        • Clinique Mutualiste L Estuaire
      • Sens, France, 89108
        • Ch Gaston Ramon; Hopital De Jour
      • Sens Cedex, France, 89108
        • Centre Hospitalier De Sens; Medecine Generale Oncologie
      • Soyaux, France, 16800
        • Centre Clinical; Oncologie Medicale
      • St Jean De Maurienne Cedex, France, 73303
        • CH de Saint Jean De Maurienne; Had St Jean De Maurienne
      • Stains, France, 93240
        • Clinique De L Estree; Oncologie Medicale
      • Ste Foy Les Lyon, France, 69110
        • Clinique Medico Chir Charcot; Chir Cancerologie
      • Strasbourg, France, 67000
        • Strasbourg Oncologie Libérale
      • Strasbourg, France, 67000
        • Institut D Oncologie Medical
      • Strasbourg, France, 67091
        • Hopital Civil; Hematologie Oncologie
      • Thonon Les Bains, France, 74203
        • Hopitaux Du Leman Site Thonon; Maternite Gynecologie
      • Toulouse, France, 31076
        • Clinique Pasteur; Oncologie Medicale
      • Toulouse, France, 31077
        • Clinique Saint Jean Languedoc; Oncologie Medicale
      • Tours, France, 37044
        • Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
      • Vandoeuvre Les Nancy, France, 54511
        • Centre Alexis Vautrin; Oncologie Medicale
      • Villeneuve D Ascq, France, 59657
        • Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with HER2-positive early breast cancer scheduled to initiate a treatment with Herceptin SC.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: approximately 13 months
approximately 13 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographic data
Time Frame: Up to 12 months
Up to 12 months
Number of modalities regarding dose and injection site of Herceptin SC administration
Time Frame: Up to 12 months
Up to 12 months
Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire
Time Frame: Every 3 months, up to 12 months
Every 3 months, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2015

Primary Completion (Actual)

November 10, 2016

Study Completion (Actual)

November 10, 2016

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Actual)

September 27, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28983

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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