Clinical trial NCT01480674: 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
Official title: A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HER2-positive metastatic breast cancer or locally advanced breast cancer whose systemic treatment included Herceptin as 1st line therapy, and who were without progression for at least 3 years after beginning Herceptin

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Tumor Hormone Receptor Status of Participants Without Progression
timeFrame: Up to 3 years
measure: Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment
timeFrame: Up to 3 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Up to 12 years
measure: Time to Progression
timeFrame: Up to 12 years
measure: Overall Survival
timeFrame: Up to 12 years
measure: Dosage Schedule of Herceptin Treatment
timeFrame: Up to 12 years
measure: Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment
timeFrame: Up to 12 years
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to 1 year
measure: The Duration of Treatment of Trastuzumab
timeFrame: Up to 1 Year
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 Service du Dr Blanc
city: Aix En Provence
country: France
facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
city: Ajaccio
country: France
facility: Chd Castelluccio; Oncologie
city: Amiens
country: France
facility: Clinique De L Europe; Pmsi
city: Amiens
country: France
facility: Clinique De L Europe; Radiotherapie Chimiotherapie
city: Arras
country: France
facility: HOP Prive Arras Les Bonnettes; Chimiotherapie
city: Aubervilliers
country: France
facility: Hopital Europeen La Roseraie;Radiotherapie
city: Auxerre
country: France
facility: Polyclinique Sainte Marguerite; Chimiotherapie
city: Beziers
country: France
facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie
city: Bordeaux
country: France
facility: Hopital Saint Andre; Oncologie 2
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; Hopital De Jour
city: Brive La Gaillarde
country: France
facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie
city: Caen
country: France
facility: Centre Francois Baclesse; Comite Sein
city: Carcassonne
country: France
facility: Ch Antoine Gayraud; Oncologie
city: Carcassonne
country: France
facility: Clinique Montreal; Chimiotherapie
city: Chalon Sur Saone
country: France
facility: Ch William Morey; Medecine 1
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin; Hopital De Jour
city: Clermont Ferrand
country: France
facility: Pole Sante Republique;Oncologie Hematologie
city: DAX
country: France
facility: Ch De Dax; Radiotherapie Oncologie
city: Dechy
country: France
facility: Centre Leonard De Vinci;Chimiotherapie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: Guilherand Granges
country: France
facility: Hopital Prive Drome Ardeche; Chir 2A 2B
city: Hyeres
country: France
facility: Clinique de L' Esperance; Oncologie
city: La Chaussee St Victor
country: France
facility: Polyclinique de Blois; Chimiotherapie Ambulatoire
city: La Roche Sur Yon
country: France
facility: CH Dptal Les Oudairies; Hematologie Oncologie
city: La Tronche
country: France
facility: Hopital Albert Michallon; Oncologie
city: Lille
country: France
facility: Polyclinique Du Bois; Centre Bourgogne
city: Lille
country: France
facility: Polyclinique Du Bois; Oncologie
city: Longjumeau
country: France
facility: Ch De Longjumeau; Hopital De Jour Et Semaine
city: Lormont
country: France
facility: Clinique Des 4 Pavillons; Chimiotherapie
city: Lyon
country: France
facility: Centre Leon Berard; Departement Oncologie Medicale
city: Lyon
country: France
facility: Polyclinique Du Beaujolais; Chimiotherapie
city: Lyon
country: France
facility: Hopital Edouard Herriot; Pavillon F Rhumatologie
city: Macon
country: France
facility: Polyclinique Du Val De Saone; Chimiotherapie
city: Marseille
country: France
facility: Hôpital Saint Joseph; Oncologie Medicale
city: Montelimar
country: France
facility: Ch De Montelimar; Radiotherapie
city: Montpellier
country: France
facility: Clinique Clementville; Hopital De Jour
city: Montpellier
country: France
facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
city: Mougins
country: France
facility: Centre Azureen De Cancerologie; Cons externes
city: Mulhouse
country: France
facility: Hopital Emile Muller; Oncologie Radiotherapie
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly; Oncology
city: Nancy
country: France
facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
city: Narbonne
country: France
facility: Clinique Des Genets; Radiotherapie
city: Neuilly Sur Seine
country: France
facility: Clinique Henry Hartmann; Oncologie
city: Nice
country: France
facility: Centre Antoine Lacassagne; Hopital De Jour A2
city: Nimes
country: France
facility: Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie
city: Nimes
country: France
facility: Polyclinique Kenval ; Radiotherapie Oncologie
city: Osny
country: France
facility: Clinique sainte marie; chimiotherapie ambulatoire
city: Paris
country: France
facility: Hopital Saint Louis; Oncologie Medicale
city: Paris
country: France
facility: Hopital Des Diaconesses; Hopital De Jour
city: Paris
country: France
facility: Ch Pitie Salpetriere; Oncologie Medicale
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Perigueux
country: France
facility: Clinique Francheville; Radiotherapie
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Hemato Secteur Jules Courmont
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Onco Secteur Jules Courmont
city: Pithiviers
country: France
facility: Ch De Pithiviers; Consult Externes
city: Reims
country: France
facility: Institut Jean Godinot; Pavillon Rubis
city: Reims
country: France
facility: Polyclinique De Courlancy; Chimiotherapie Ambulatoire
city: Rennes
country: France
facility: Centre Eugene Marquis; Unite Huguenin
city: Rouen
country: France
facility: Clinique Saint Hilaire; Sce Chimiotherapie
city: Saint Gregoire
country: France
facility: Chp Saint Gregoire; Cancerologie Radiotherapie
city: Saint Herblain
country: France
facility: Ico Rene Gauducheau; Oncologie
city: Saint Jean
country: France
facility: Clinique de L'Union; Oncologie
city: Saint Nazaire
country: France
facility: Centre Radiotherapie Etienne Dolet
city: Saint Quentin
country: France
facility: Ch De Saint Quentin; Medecine B10
city: Senlis
country: France
facility: CH De Senlis; Medecine 2
city: Soissons
country: France
facility: Ch De Soissons; Medecine Ambulatoire
city: St Priest En Jarez
country: France
facility: Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: Toulouse
country: France
facility: Clinique Pasteur; Oncologie Medicale
city: Toulouse
country: France
facility: Chevelle Christian; Centre De Radiotherapie
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Verdun
country: France
facility: Hopital Saint Nicolas; Pneumologie
city: Villejuif
country: France
facility: Institut Gustave Roussy; Comite 5
city: Villejuif
country: France
facility: Institut Gustave Roussy; Departement Oncologie Medicale
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: