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A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01152606
First received: June 28, 2010
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. Data will be collected from centre's medical records for up to 5 years or death.


Condition Intervention
Breast Cancer
 Drug: trastuzumab [Herceptin]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death [ Time Frame: On treatment and up to 5 years follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to onset and the time to recovery of symptomatic congestive heart failure [ Time Frame: On treatment and up to 5 years follow-up ] [ Designated as safety issue: Yes ]
  • Incidence of asymptomatic cardiac failure and other significant cardiac conditions [ Time Frame: On treatment and up to 5 years follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 3942
Study Start Date: August 2007
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: trastuzumab [Herceptin]
There is no planned investigational product or a treatment regimen prescribed by this protocol. Decision about a treatment regimen will be made according to the local practice and in the best interest of individual patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HER2-positive Breast Cancer

Criteria

Inclusion Criteria:

  • All patients who are considered candidates to receive Herceptin for this indication

Exclusion Criteria:

  • Patients for whom Herceptin is contraindicated
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152606

  Show 197 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01152606     History of Changes
Other Study ID Numbers: BO20652
Study First Received: June 28, 2010
Last Updated: May 23, 2013
Health Authority: Germany: Federal Institute for Drigs and Medical Devices

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013