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Breast CancerNCT02286362

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

An observational study of Breast Cancer, run by Hoffmann-La Roche at 97 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
How many people
510 participants
Where
97 sitesFrance
Study dates
14 Jan 2015to 10 Nov 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Patients previously treated with Herceptin SC treatment

Trial locations and contacts

97 sites in 1 country.

97 sites in 1 country

France97 sites

  • Clinique Du Docteur Calabet; Cromg

    Agen, 47000

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

    Aix-en-Provence, 13616

  • Ch Du Pays D Aix; Maternite Gynecologie

    Aix-en-Provence, 13616

  • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

    Aix-en-Provence, 13617

  • Centre Hospitalier Albi; Oncologie

    Albi, 81000

  • Clinique Claude Bernard; Onco Hematologie

    Albi, 81030

  • Hopital Prive D Antony; Oncologie

    Antony, 92166

  • Cmc De Tronquieres;Chimiotherapie Et Radiotherapie

    Aurillac, 15013

  • Ch D Auxerre; Oncologie

    Auxerre, 89011

  • Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

    Bastia, 20200

  • Hopital De Falconaja Furiani; Hopital De Jour

    Bastia, 20604

  • Centre Oncologie Du Pays Basque

    Bayonne, 64100

  • HOPITAL JEAN MINJOZ; Oncologie

    Besançon, 25030

  • Centre Pierre Curie

    Beuvry, 62660

  • Ch De Beziers; Hematologie

    Béziers, 34525

  • Hopital Avicenne; Cancerologie

    Bobigny, 93009

  • Clinique Tivoli; Chimiotherapie Radiotherapie

    Bordeaux, 33030

  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

    Bordeaux, 33077

  • Centre Hospitalier Fleyriat; Oncologie/Hematologie

    Bourg-en-Bresse, 01012

  • Hopital Augustin Morvan; Federation De Cancerologie

    Brest, 29200

  • Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

    Brest, 29220

  • CMC de Bligny; Oncologie Court Sejour

    Briis-sous-Forges, 91640

  • Hopital Pierre Nouveau; Medecine A

    Cannes, 06400

  • CH Carcassonne; Service Onco Hematologie

    Carcassonne, 11000

  • Clinique Montreal; Chimiotherapie

    Carcassonne

  • Medipole De Savoie; Departement Oncologie

    Challes-les-Eaux, 73190

  • Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

    Champigny-sur-Marne, 94507

  • CH de Cholet; oncologie

    Cholet, 49325

  • Hopital Antoine Beclere; Hopital De Jour

    Clamart, 92141

  • Centre De Radiotherapie Et D'Oncologie; Oncologie

    Compiègne, 60200

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

    Creil, 60109

  • Chi De Creteil; Radiotherapie Oncologie

    Créteil, 94010

  • Hopital Henri Mondor; Oncologie Medicale

    Créteil, 94010

  • Centre Leonard De Vinci;Chimiotherapie

    Dechy, 59187

  • Centre De Radiotherapie Du Parc

    Dijon, 21000

  • Ch De La Dracenie; Hopital De Jour

    Draguignan, 83007

  • Chi Emile Durkheim Site Epinal; Oncologie

    Épinal, 88021

  • Clinique Claude Bernard; Chimiotherapie

    Ermont, 95120

  • Chi De Frejus Saint Raphael; Oncologie

    Fréjus, 83608

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

    Gap, 05000

  • Centre Mistral; Chirurgie Cancerologie Gynecologiques

    Guilherand-Granges, 07500

  • CH de Marne la vallee; Oncologie Medicale

    Jossigny, 77600

  • Hopital Albert Michallon; Oncologie

    La Tronche, 38700

  • Hopital Louis Pasteur; Oncologie Hematologie

    Le Coudray, 28630

  • Ch Du Mans; Medecine Hematologie Oncologie

    Le Mans, 72037

  • Polyclinique Du Bois; Oncologie

    Lille, 59003

  • Clinique Chenieux; Oncology

    Limoges, 87039

  • Ch De Longjumeau; Hopital De Jour Et Semaine

    Longjumeau, 91161

  • Ch De Lons Le Saunier; Medecine 5

    Lons-le-Saunier, 39016

  • Ch Bretagne Sud Site Scorff; Oncologie Medicale

    Lorient, 56100

  • Clinique De La Sauvegarde; Chimiotherapie

    Lyon, 69337

  • Clinique Saint Faron; Sce Oncologie Radiotherapie

    Mareuil-lès-Meaux, 77100

  • Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie

    Marseille, 13004

  • Hopital Clinique Claude Bernard; Oncologie Medicale

    Metz, 57000

  • Hopital Layne; Medecine Ambulatoire

    Mont-de-Marsan, 40024

  • Ghi Le Raincy Montfermeil; Oncologie Medicale

    Montfermeil, 93370

  • Ch De Montlucon; Hematologie Cancerologie

    Montluçon, 03100

  • Clinique Clementville; Hopital De Jour

    Montpellier, 34070

  • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

    Nancy, 54100

  • Centre Catherine de Sienne; Chimiotherapie

    Nantes, 44202

  • Polyclinique Du Languedoc; Chimiotherapie

    Narbonne, 11780

  • Hopital Caremeau; Hematologie Oncologie

    Nîmes, 30029

  • Hopital Caremeau; Maternite Gynecologie

    Nîmes, 30029

  • Clinique Valdegour

    Nîmes, 30900

  • Ch Georges Renon; Oncologie Radiotherapie

    Niort, 79021

  • CROM

    Osny, 95520

  • Ch Pitie Salpetriere; Oncologie Medicale

    Paris, 75651

  • GH Paris Saint Joseph; Hopital De Jour Oncologie

    Paris, 75674

  • Ch Francois Mitterrand; Medecine Oncologie

    Pau, 64046

  • Polyclinique Francheville; Med Chimiotherapie Radiotherapie

    Périgueux, 24000

  • Centre Catalan D' Oncologie

    Perpignan, 66000

  • Hopital Saint Jean; Centre Henri Pujol

    Perpignan, 66046

  • CH Rene Dubos; Oncologie

    Pontoise, 95300

  • CH Annecy Genevois site Annecy; Oncologie

    Pringy, 74374

  • Chi De Cornouaille; Oncologie Hospitalisation

    Quimper, 29107

  • Institut Jean Godinot; Pavillon Rubis

    Reims, 51056

  • Clinique de la Theuillerie; Oncologie

    Ris-Orangis, 91130

  • Clinique Armoricaine Radiologie; Cons Externes

    Saint-Brieuc, 22015

  • Clinique Francois 1er; Service De Chimiotherapie

    Saint-Dizier, 52100

  • Chp Saint Gregoire; Cancerologie Radiotherapie

    Saint-Grégoire, 35768

  • Clinique de L'Union; Oncologie

    Saint-Jean, 31240

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

    Saint-Jean-de-Maurienne, 73303

  • Clinique Mutualiste L Estuaire

    Saint-Nazaire, 44606

  • Centre Hospitalier De Sens; Medecine Generale Oncologie

    Sens, 89108

  • Ch Gaston Ramon; Hopital De Jour

    Sens, 89108

  • Centre Clinical; Oncologie Medicale

    Soyaux, 16800

  • Clinique De L Estree; Oncologie Medicale

    Stains, 93240

  • Clinique Medico Chir Charcot; Chir Cancerologie

    Ste Foy Les Lyon, 69110

  • Institut D Oncologie Medical

    Strasbourg, 67000

  • Strasbourg Oncologie Libérale

    Strasbourg, 67000

  • Hopital Civil; Hematologie Oncologie

    Strasbourg, 67091

  • Hopitaux Du Leman Site Thonon; Maternite Gynecologie

    Thonon-les-Bains, 74203

  • Clinique Pasteur; Oncologie Medicale

    Toulouse, 31076

  • Clinique Saint Jean Languedoc; Oncologie Medicale

    Toulouse, 31077

  • Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

    Tours, 37044

  • Centre Alexis Vautrin; Oncologie Medicale

    Vandœuvre-lès-Nancy, 54511

  • Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

    Villeneuve-d'Ascq, 59657

Other trials in France

About this study

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.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02286362
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: approximately 13 months

Secondary outcomes (3)

  1. Demographic data

    Measured: Up to 12 months

  2. Number of modalities regarding dose and injection site of Herceptin SC administration

    Measured: Up to 12 months

  3. Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire

    Measured: Every 3 months, up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2014 (estimated)
  2. Study start14 Jan 2015
  3. Primary completion10 Nov 2016
  4. Study completion10 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02286362
Sponsor's protocol ID
ML28983
Status last verified
Sep 2017
First submitted
30 Oct 2014
Last updated
27 Sep 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Hoffmann-La Roche at 97 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: approximately 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02286362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2017.

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