An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
Conditions
Breast Cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- Patients previously treated with Herceptin SC treatment
Locations
Agen, France
Status: Recruiting
Aix En Provence, France
Status: Recruiting
Aix En Provence, France
Status: Recruiting
Albi, France
Status: Recruiting
Antony, France
Status: Recruiting
Auxerre, France
Status: Recruiting
Bastia, France
Status: Recruiting
Bastia, France
Status: Recruiting
Bayonne, France
Status: Recruiting
Besancon, France
Status: Recruiting
Beuvry, France
Status: Recruiting
Beziers, France
Status: Recruiting
Bobigny, France
Status: Recruiting
Bordeaux, France
Status: Recruiting
Bordeaux, France
Status: Recruiting
Bourg En Bresse, France
Status: Recruiting
Brest, France
Status: Recruiting
Brest, France
Status: Recruiting
Briis Sous Forges, France
Status: Recruiting
Champigny Sur Marne, France
Status: Recruiting
Clamart Cedex, France
Status: Recruiting
Creil Cedex 1, France
Status: Recruiting
Creteil, France
Status: Recruiting
Dechy, France
Status: Recruiting
Dijon, France
Status: Recruiting
Draguignan, France
Status: Recruiting
Epinal, France
Status: Recruiting
GAP, France
Status: Recruiting
Guilherand Granges, France
Status: Recruiting
Jossigny, France
Status: Recruiting
Le Coudray, France
Status: Recruiting
Le Mans, France
Status: Recruiting
Lille, France
Status: Recruiting
Limoges, France
Status: Recruiting
Longjumeau, France
Status: Recruiting
Lons Le Saunier, France
Status: Recruiting
Lorient, France
Status: Recruiting
Lyon, France
Status: Recruiting
Mareuil Les Meaux, France
Status: Recruiting
Marseille, France
Status: Recruiting
Metz, France
Status: Recruiting
Mont-de-marsan, France
Status: Recruiting
Montlucon, France
Status: Recruiting
Montpellier, France
Status: Recruiting
Nancy, France
Status: Recruiting
Nantes, France
Status: Recruiting
Narbonne, France
Status: Recruiting
Nimes, France
Status: Recruiting
Nimes, France
Status: Recruiting
Niort, France
Status: Recruiting
Osny, France
Status: Recruiting
Paris, France
Status: Recruiting
Pau, France
Status: Recruiting
Perigueux, France
Status: Recruiting
Perpignan, France
Status: Recruiting
Perpignan, France
Status: Recruiting
Pontoise, France
Status: Recruiting
Quimper, France
Status: Recruiting
Ris Orangis, France
Status: Recruiting
Saint Brieuc, France
Status: Recruiting
Saint Dizier, France
Status: Recruiting
Saint Gregoire, France
Status: Recruiting
Saint Jean, France
Status: Recruiting
Saint Nazaire, France
Status: Recruiting
Sens Cedex, France
Status: Recruiting
Sens, France
Status: Recruiting
Soyaux, France
Status: Recruiting
St Jean De Maurienne Cedex, France
Status: Recruiting
Stains, France
Status: Recruiting
Ste Foy Les Lyon, France
Status: Recruiting
Strasbourg, France
Status: Recruiting
Thonon Les Bains, France
Status: Recruiting
Toulouse, France
Status: Recruiting
Toulouse, France
Status: Recruiting
Tours, France
Status: Recruiting
Vandoeuvre Les Nancy, France
Status: Recruiting
Villejuif, France
Status: Not yet recruiting
Villeneuve D Ascq, France
Status: Recruiting
Start Date
January 2015
Completion Date
January 2018
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page