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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01615068
First received: June 6, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

This multi-center, prospective observational study will evaluate the treatment p atterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer d iagnosis that has not been previously treated with systemic therapy; patients ma y 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
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: 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 142 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01615068     History of Changes
Other Study ID Numbers: ML28257
Study First Received: June 6, 2012
Last Updated: September 15, 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 September 22, 2014