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

This study is currently recruiting participants.
Verified April 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01615068
First received: June 6, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: 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)).

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Distribution of patients receiving unique treatment regimen/sequence of treatment regimens [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Post-progression survival (PPS) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Time-to-treatment failure (TTF) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Response rate (RR) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Patient-reported outcome assessment (PRO) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue and whole blood samples


Estimated Enrollment: 1000
Study Start Date: June 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615068

Contacts
Contact: Reference Study ID Number: ML28257 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 139 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01615068     History of Changes
Other Study ID Numbers: ML28257
Study First Received: June 6, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014