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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480674
First Posted: November 29, 2011
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention
Breast Cancer Drug: Trastuzumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tumor Hormone Receptor Status of Participants Without Progression [ Time Frame: 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 [ Time Frame: 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:
  • Progression-free Survival [ Time Frame: 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 [ Time Frame: 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.

  • Overall Survival [ Time Frame: 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.

  • Dosage Schedule of Herceptin Treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 1 Year ]
    Total treatment duration and duration of the first line of treatment is reported.


Enrollment: 160
Actual Study Start Date: March 28, 2011
Study Completion Date: November 16, 2012
Primary Completion Date: November 16, 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Trastuzumab

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480674


  Hide Study Locations
Locations
France
Clinique Du Docteur Calabet; Cromg
Agen, France, 47000
C.H. Du Pays D'aix En Provence Service du Dr Blanc
Aix En Provence, France, 13616
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix En Provence, France, 13617
Chd Castelluccio; Oncologie
Ajaccio, France, 20176
Clinique De L Europe; Pmsi
Amiens, France, 80090
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, France, 80090
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, France, 62012
Hopital Europeen La Roseraie;Radiotherapie
Aubervilliers, France, 93308
Polyclinique Sainte Marguerite; Chimiotherapie
Auxerre, France, 89000
Clinique Champeau Mediterranee; Radiotherapie Oncologie
Beziers, France, 34535
Hopital Saint Andre; Oncologie 2
Bordeaux, France, 33075
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, France, 33077
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg En Bresse, France, 01012
Hopital Augustin Morvan; Hopital De Jour
Brest, France, 29609
Ch De Brive La Gaillarde; Radiotherapie Oncologie
Brive La Gaillarde, France, 19312
Centre Francois Baclesse; Comite Sein
Caen, France, 14076
Ch Antoine Gayraud; Oncologie
Carcassonne, France, 11890
Clinique Montreal; Chimiotherapie
Carcassonne, France
Ch William Morey; Medecine 1
Chalon Sur Saone, France, 71321
Centre Jean Perrin; Hopital De Jour
Clermont Ferrand, France, 63011
Pole Sante Republique;Oncologie Hematologie
Clermont Ferrand, France, 63050
Ch De Dax; Radiotherapie Oncologie
DAX, France, 40107
Centre Leonard De Vinci;Chimiotherapie
Dechy, France, 59187
Centre Georges Francois Leclerc; Oncologie 3
Dijon, France, 21079
Hopital Prive Drome Ardeche; Chir 2A 2B
Guilherand Granges, France, 07500
Clinique de L' Esperance; Oncologie
Hyeres, France, 83400
Polyclinique de Blois; Chimiotherapie Ambulatoire
La Chaussee St Victor, France, 41260
CH Dptal Les Oudairies; Hematologie Oncologie
La Roche Sur Yon, France, 85925
Hopital Albert Michallon; Oncologie
La Tronche, France, 38700
Polyclinique Du Bois; Centre Bourgogne
Lille, France, 59000
Polyclinique Du Bois; Oncologie
Lille, France, 59003
Ch De Longjumeau; Hopital De Jour Et Semaine
Longjumeau, France, 91161
Clinique Des 4 Pavillons; Chimiotherapie
Lormont, France, 33310
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373
Polyclinique Du Beaujolais; Chimiotherapie
Lyon, France, 69400
Hopital Edouard Herriot; Pavillon F Rhumatologie
Lyon, France, 69437
Polyclinique Du Val De Saone; Chimiotherapie
Macon, France, 71000
Hôpital Saint Joseph; Oncologie Medicale
Marseille, France, 13285
Ch De Montelimar; Radiotherapie
Montelimar, France, 26216
Clinique Clementville; Hopital De Jour
Montpellier, France, 34070
Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
Montpellier, France, 34967
Centre Azureen De Cancerologie; Cons externes
Mougins, France, 06250
Hopital Emile Muller; Oncologie Radiotherapie
Mulhouse, France, 68070
Centre D'Oncologie de Gentilly; Oncology
Nancy, France, 54100
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
Nancy, France, 54100
Clinique Des Genets; Radiotherapie
Narbonne, France, 11108
Clinique Henry Hartmann; Oncologie
Neuilly Sur Seine, France, 92200
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, France, 06189
Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie
Nimes, France, 30029
Polyclinique Kenval ; Radiotherapie Oncologie
Nimes, France, 30900
Clinique sainte marie; chimiotherapie ambulatoire
Osny, France, 95520
Hopital Saint Louis; Oncologie Medicale
Paris, France, 75475
Hopital Des Diaconesses; Hopital De Jour
Paris, France, 75571
Ch Pitie Salpetriere; Oncologie Medicale
Paris, France, 75651
HOPITAL TENON; Cancerologie Medicale
Paris, France, 75970
Clinique Francheville; Radiotherapie
Perigueux, France, 24000
Ch Lyon Sud; Hemato Secteur Jules Courmont
Pierre Benite, France, 69495
Ch Lyon Sud; Onco Secteur Jules Courmont
Pierre Benite, France, 69495
Ch De Pithiviers; Consult Externes
Pithiviers, France, 45307
Institut Jean Godinot; Pavillon Rubis
Reims, France, 51056
Polyclinique De Courlancy; Chimiotherapie Ambulatoire
Reims, France, 51057
Centre Eugene Marquis; Unite Huguenin
Rennes, France, 35042
Clinique Saint Hilaire; Sce Chimiotherapie
Rouen, France, 76044
Chp Saint Gregoire; Cancerologie Radiotherapie
Saint Gregoire, France, 35768
Ico Rene Gauducheau; Oncologie
Saint Herblain, France, 44805
Clinique de L'Union; Oncologie
Saint Jean, France, 31240
Centre Radiotherapie Etienne Dolet
Saint Nazaire, France, 44600
Ch De Saint Quentin; Medecine B10
Saint Quentin, France, 02321
CH De Senlis; Medecine 2
Senlis, France, 60309
Ch De Soissons; Medecine Ambulatoire
Soissons, France, 02209
Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
St Priest En Jarez, France, 42271
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Clinique Pasteur; Oncologie Medicale
Toulouse, France, 31076
Chevelle Christian; Centre De Radiotherapie
Toulouse, France
Centre Alexis Vautrin; Oncologie Medicale
Vandoeuvre Les Nancy, France, 54511
Hopital Saint Nicolas; Pneumologie
Verdun, France, 55107
Institut Gustave Roussy; Comite 5
Villejuif, France, 94805
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, France, 94805
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01480674     History of Changes
Other Study ID Numbers: ML23001
First Submitted: August 18, 2011
First Posted: November 29, 2011
Results First Submitted: January 27, 2016
Results First Posted: February 24, 2016
Last Update Posted: August 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents