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

Completed

Conditions: Breast Cancer

Interventions: Drug: Trastuzumab

Registration Number: NCT01480674

Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 160

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trastuzumab	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.

Primary Outcome Measures

Name	Time	Method
Tumor Hormone Receptor Status of Participants Without Progression	Up to 3 years	The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.
Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment	Up to 3 years	Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 12 years	The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.
Progression-free Survival	Up to 12 years	The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.
Time to Progression	Up to 12 years	The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.
Dosage Schedule of Herceptin Treatment	Up to 12 years	Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.
Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment	Up to 12 years	Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.
Number of Participants With Any Adverse Events and Serious Adverse Events	Up to 1 year	An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.
The Duration of Treatment of Trastuzumab	Up to 1 Year	Total treatment duration and duration of the first line of treatment is reported.

Trial Locations

Locations (78): Ch De Brive La Gaillarde; Radiotherapie Oncologie
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Brive La Gaillarde, France
Ch William Morey; Medecine 1
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Chalon Sur Saone, France
Centre Jean Perrin; Hopital De Jour
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Clermont Ferrand, France
Clinique Des 4 Pavillons; Chimiotherapie
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Lormont, France
Centre Leon Berard; Departement Oncologie Medicale
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Lyon, France
Clinique Des Genets; Radiotherapie
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Narbonne, France
Institut Claudius Regaud; Departement Oncologie Medicale
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Toulouse, France
Clinique Pasteur; Oncologie Medicale
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Toulouse, France
Institut Gustave Roussy; Departement Oncologie Medicale
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Villejuif, France
Centre Alexis Vautrin; Oncologie Medicale
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Vandoeuvre Les Nancy, France
Institut Gustave Roussy; Comite 5
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Villejuif, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
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Aix En Provence, France
Clinique Champeau Mediterranee; Radiotherapie Oncologie
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Beziers, France
Clinique Du Docteur Calabet; Cromg
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Agen, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
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Aix En Provence, France
Clinique Montreal; Chimiotherapie
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Carcassonne, France
Chd Castelluccio; Oncologie
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Ajaccio, France
Hopital Europeen La Roseraie;Radiotherapie
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Aubervilliers, France
Clinique De L Europe; Radiotherapie Chimiotherapie
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Amiens, France
Hopital Saint Andre; Oncologie 2
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Bordeaux, France
Hopital Augustin Morvan; Hopital De Jour
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Brest, France
Clinique De L Europe; Pmsi
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Amiens, France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
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Bordeaux, France
Hopital Prive Drome Ardeche; Chir 2A 2B
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Guilherand Granges, France
Polyclinique Du Beaujolais; Chimiotherapie
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Lyon, France
Clinique Clementville; Hopital De Jour
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Montpellier, France
Hopital Edouard Herriot; Pavillon F Rhumatologie
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Lyon, France
Hopital Emile Muller; Oncologie Radiotherapie
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Mulhouse, France
Centre D'Oncologie de Gentilly; Oncology
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Nancy, France
HOPITAL TENON; Cancerologie Medicale
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Paris, France
Ch Lyon Sud; Onco Secteur Jules Courmont
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Pierre Benite, France
Polyclinique De Courlancy; Chimiotherapie Ambulatoire
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Reims, France
Centre Eugene Marquis; Unite Huguenin
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Rennes, France
Clinique Saint Hilaire; Sce Chimiotherapie
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Rouen, France
Chevelle Christian; Centre De Radiotherapie
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Toulouse, France
Ch De Dax; Radiotherapie Oncologie
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DAX, France
Centre Leonard De Vinci;Chimiotherapie
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Dechy, France
Pole Sante Republique;Oncologie Hematologie
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Clermont Ferrand, France
Clinique de L' Esperance; Oncologie
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Hyeres, France
Polyclinique de Blois; Chimiotherapie Ambulatoire
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La Chaussee St Victor, France
Hopital Albert Michallon; Oncologie
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La Tronche, France
CH Dptal Les Oudairies; Hematologie Oncologie
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La Roche Sur Yon, France
Polyclinique Du Val De Saone; Chimiotherapie
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Macon, France
Hôpital Saint Joseph; Oncologie Medicale
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Marseille, France
Ch De Montelimar; Radiotherapie
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Montelimar, France
Centre Antoine Lacassagne; Hopital De Jour A2
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Nice, France
Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie
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Nimes, France
Clinique Henry Hartmann; Oncologie
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Neuilly Sur Seine, France
Polyclinique Kenval ; Radiotherapie Oncologie
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Nimes, France
Hopital Des Diaconesses; Hopital De Jour
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Paris, France
Ch Pitie Salpetriere; Oncologie Medicale
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Paris, France
Hopital Saint Louis; Oncologie Medicale
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Paris, France
Clinique sainte marie; chimiotherapie ambulatoire
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Osny, France
Ch De Pithiviers; Consult Externes
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Pithiviers, France
Institut Jean Godinot; Pavillon Rubis
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Reims, France
Ico Rene Gauducheau; Oncologie
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Saint Herblain, France
Chp Saint Gregoire; Cancerologie Radiotherapie
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Saint Gregoire, France
Clinique de L'Union; Oncologie
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Saint Jean, France
Ch De Saint Quentin; Medecine B10
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Saint Quentin, France
Centre Radiotherapie Etienne Dolet
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Saint Nazaire, France
CH De Senlis; Medecine 2
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Senlis, France
Ch De Soissons; Medecine Ambulatoire
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Soissons, France
Hopital Saint Nicolas; Pneumologie
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Verdun, France
HOP Prive Arras Les Bonnettes; Chimiotherapie
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Arras, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
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Bourg En Bresse, France
Centre Georges Francois Leclerc; Oncologie 3
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Dijon, France
Ch De Longjumeau; Hopital De Jour Et Semaine
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Longjumeau, France
Polyclinique Du Bois; Centre Bourgogne
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Lille, France
Polyclinique Sainte Marguerite; Chimiotherapie
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Auxerre, France
Centre Francois Baclesse; Comite Sein
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Caen, France
Ch Antoine Gayraud; Oncologie
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Carcassonne, France
Polyclinique Du Bois; Oncologie
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Lille, France
Ch Lyon Sud; Hemato Secteur Jules Courmont
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Pierre Benite, France
Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
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Montpellier, France
Centre Azureen De Cancerologie; Cons externes
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Mougins, France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
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Nancy, France
Clinique Francheville; Radiotherapie
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Perigueux, France
Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
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St Priest En Jarez, France