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An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

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ClinicalTrials.gov Identifier: NCT01615068
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.

Condition or disease
Breast Cancer

Study Design

Study Type : Observational
Actual Enrollment : 1007 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort Study Of Treatment Patterns And Outcomes In Patients With HER2 Positive (Her2+) Metastatic Breast Cancer (SystHERs Registry (Systematic Therapies for HER2+ Metastatic Breast Cancer Study)).
Actual Study Start Date : June 5, 2012
Primary Completion Date : November 16, 2017
Study Completion Date : November 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Cohort


Outcome Measures

Primary Outcome Measures :
  1. Distribution of patients receiving unique treatment regimen/sequence of treatment regimens [ Time Frame: Up to 8 years ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 8 years ]
  2. Overall survival (OS) [ Time Frame: Up to 8 years ]
  3. Post-progression survival (PPS) [ Time Frame: Up to 8 years ]
  4. Time-to-treatment failure (TTF) [ Time Frame: Up to 8 years ]
  5. Response rate (RR) [ Time Frame: Up to 8 years ]
  6. Safety: Incidence of adverse events [ Time Frame: Up to 8 years ]
  7. Patient-reported outcome assessment (PRO) [ Time Frame: Up to 8 years ]

Biospecimen Retention:   Samples With DNA
Tissue and whole blood samples

Eligibility Criteria

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
Patients with HER2 positive (HER2+) metastatic breast cancer
Criteria

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment
  • Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

  • Any inability to provide informed consent
Contacts and Locations

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): NCT01615068


  Show 142 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01615068     History of Changes
Other Study ID Numbers: ML28257
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases