An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years

NCT ID: NCT01480674

Last Updated: 2017-08-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-28

Study Completion Date

2012-11-16

Brief Summary

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This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.

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

OTHER

Study Groups

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Trastuzumab

Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.

Trastuzumab

Intervention Type DRUG

Interventions

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Trastuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patients, \>/= 18 years of age
* HER2-positive metastatic breast cancer or locally advanced breast cancer
* Systemic treatment included Herceptin as 1st line therapy
* Without progression for at least 3 years after the beginning of Herceptin treatment
* Alive or not alive and treated or not treated with Herceptin at the time of inclusion

Exclusion Criteria

* Disease progression \<3 years after beginning 1st-line therapy with Herceptin
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 Service du Dr Blanc

Aix-en-Provence, , France

Site Status

Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

Aix-en-Provence, , France

Site Status

Chd Castelluccio; Oncologie

Ajaccio, , France

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Clinique De L Europe; Pmsi

Amiens, , France

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Clinique De L Europe; Radiotherapie Chimiotherapie

Amiens, , France

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HOP Prive Arras Les Bonnettes; Chimiotherapie

Arras, , France

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Hopital Europeen La Roseraie;Radiotherapie

Aubervilliers, , France

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Polyclinique Sainte Marguerite; Chimiotherapie

Auxerre, , France

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Clinique Champeau Mediterranee; Radiotherapie Oncologie

Béziers, , France

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Hopital Saint Andre; Oncologie 2

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; Hopital De Jour

Brest, , France

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Ch De Brive La Gaillarde; Radiotherapie Oncologie

Brive-la-Gaillarde, , France

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Centre Francois Baclesse; Comite Sein

Caen, , France

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Ch Antoine Gayraud; Oncologie

Carcassonne, , France

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Clinique Montreal; Chimiotherapie

Carcassonne, , France

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Ch William Morey; Medecine 1

Chalon-sur-Saône, , France

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Centre Jean Perrin; Hopital De Jour

Clermont-Ferrand, , France

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Pole Sante Republique;Oncologie Hematologie

Clermont-Ferrand, , France

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Ch De Dax; Radiotherapie Oncologie

Dax, , France

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Centre Leonard De Vinci;Chimiotherapie

Dechy, , France

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Centre Georges Francois Leclerc; Oncologie 3

Dijon, , France

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Hopital Prive Drome Ardeche; Chir 2A 2B

Guilherand-Granges, , France

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Clinique de L' Esperance; Oncologie

Hyères, , France

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Polyclinique de Blois; Chimiotherapie Ambulatoire

La Chaussée-Saint-Victor, , France

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CH Dptal Les Oudairies; Hematologie Oncologie

La Roche-sur-Yon, , France

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Hopital Albert Michallon; Oncologie

La Tronche, , France

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Polyclinique Du Bois; Centre Bourgogne

Lille, , France

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Polyclinique Du Bois; Oncologie

Lille, , France

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Ch De Longjumeau; Hopital De Jour Et Semaine

Longjumeau, , France

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Clinique Des 4 Pavillons; Chimiotherapie

Lormont, , France

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Centre Leon Berard; Departement Oncologie Medicale

Lyon, , France

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Polyclinique Du Beaujolais; Chimiotherapie

Lyon, , France

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Hopital Edouard Herriot; Pavillon F Rhumatologie

Lyon, , France

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Hôpital Saint Joseph; Oncologie Medicale

Marseille, , France

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Polyclinique Du Val De Saone; Chimiotherapie

Mâcon, , France

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Ch De Montelimar; Radiotherapie

Montélimar, , France

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Clinique Clementville; Hopital De Jour

Montpellier, , France

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Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

Montpellier, , France

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Centre Azureen De Cancerologie; Cons externes

Mougins, , France

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Hopital Emile Muller; Oncologie Radiotherapie

Mulhouse, , France

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Centre D'Oncologie de Gentilly; Oncology

Nancy, , France

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Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

Nancy, , France

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Clinique Des Genets; Radiotherapie

Narbonne, , France

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Clinique Henry Hartmann; Oncologie

Neuilly-sur-Seine, , France

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Centre Antoine Lacassagne; Hopital De Jour A2

Nice, , France

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Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie

Nîmes, , France

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Polyclinique Kenval ; Radiotherapie Oncologie

Nîmes, , France

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Clinique sainte marie; chimiotherapie ambulatoire

Osny, , France

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Hopital Saint Louis; Oncologie Medicale

Paris, , France

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Hopital Des Diaconesses; Hopital De Jour

Paris, , France

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Ch Pitie Salpetriere; Oncologie Medicale

Paris, , France

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HOPITAL TENON; Cancerologie Medicale

Paris, , France

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Clinique Francheville; Radiotherapie

Périgueux, , France

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Ch Lyon Sud; Hemato Secteur Jules Courmont

Pierre-Bénite, , France

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Ch Lyon Sud; Onco Secteur Jules Courmont

Pierre-Bénite, , France

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Ch De Pithiviers; Consult Externes

Pithiviers, , France

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Institut Jean Godinot; Pavillon Rubis

Reims, , France

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Polyclinique De Courlancy; Chimiotherapie Ambulatoire

Reims, , France

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Centre Eugene Marquis; Unite Huguenin

Rennes, , France

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Clinique Saint Hilaire; Sce Chimiotherapie

Rouen, , France

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Chp Saint Gregoire; Cancerologie Radiotherapie

Saint-Grégoire, , France

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Ico Rene Gauducheau; Oncologie

Saint-Herblain, , France

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Clinique de L'Union; Oncologie

Saint-Jean, , France

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Centre Radiotherapie Etienne Dolet

Saint-Nazaire, , France

Site Status

Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0

Saint-Priest-en-Jarez, , France

Site Status

Ch De Saint Quentin; Medecine B10

Saint-Quentin, , France

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CH De Senlis; Medecine 2

Senlis, , France

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Ch De Soissons; Medecine Ambulatoire

Soissons, , France

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Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, , France

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Clinique Pasteur; Oncologie Medicale

Toulouse, , France

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Chevelle Christian; Centre De Radiotherapie

Toulouse, , France

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Centre Alexis Vautrin; Oncologie Medicale

Vandœuvre-lès-Nancy, , France

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Hopital Saint Nicolas; Pneumologie

Verdun, , France

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Institut Gustave Roussy; Comite 5

Villejuif, , France

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Institut Gustave Roussy; Departement Oncologie Medicale

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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ML23001

Identifier Type: -

Identifier Source: org_study_id

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