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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01991340
Other study ID # ML21975
Secondary ID
Status Completed
Phase N/A
First received November 7, 2013
Last updated November 18, 2013
Start date November 2008
Est. completion date February 2013

Study information

Verified date November 2013
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority unknown: unknown
Study type Observational

Clinical Trial Summary

This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.


Recruitment information / eligibility

Status Completed
Enrollment 657
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically confirmed HER2-positive breast cancer

- Eligible to receive Herceptin as per Summary of Product Characteristics

Exclusion Criteria:

- Contra-indications according to Summary of Product Characteristics

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Algeria,  Morocco, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety: Incidence of adverse events up to approximately 4.5 years No
Secondary Incidence of symptomatic congestive heart failure (NYHA class II, III and IV) up to approximately 4.5 years No
Secondary Incidence of asymptomatic LVEF decline up to approximately 4.5 years No
Secondary Frequency of treatment discontinuations/interruptions up to approximately 4.5 years No
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