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: August 4, 2014
Last verified: August 2014
  Purpose

This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedure s/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 yea rs 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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 2014
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 August 18, 2014