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

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ClinicalTrials.gov Identifier: NCT01152606
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Drug: trastuzumab [Herceptin]

Study Type : Observational
Actual Enrollment : 3942 participants
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
Actual Study Start Date : August 30, 2007
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : May 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Time to onset and the time to recovery of symptomatic congestive heart failure [ Time Frame: On treatment and up to 5 years follow-up ]
  2. Incidence of asymptomatic cardiac failure and other significant cardiac conditions [ Time Frame: On treatment and up to 5 years follow-up ]


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:   All
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

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): NCT01152606


  Show 205 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01152606     History of Changes
Other Study ID Numbers: BO20652
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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