Trial Information
Multicenter, Single-arm, Observational Study of Mean Duration of Trastuzumab Treatment for Early and Metastatic Breast Cancer in Romanian Population (HERODOT Study)
Inclusion Criteria:
- Female patients, >/= 18 years of age
- HER2-positive breast cancer
- Treated with Herceptin in accordance with Summary of Product Characteristics and
local protocols
- Written informed consent to data collection
Exclusion Criteria:
- Any contraindication to Herceptin
- Clinically relevant cardiovascular disorder or disease
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Mean duration of Herceptin treatment in routine clinical practice, from start of treatment to permanent discontinuation
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Romania: National Medicines Agency
Study ID:
ML25235
NCT ID:
NCT01187381
Start Date:
April 2010
Completion Date:
July 2013
Related Keywords:
- Breast Cancer
- Breast Neoplasms