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NCT Number: NCT01615068

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent'S Hospital; Birmingham Hematology Oncology Associates, Llc, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Distribution of patients receiving unique treatment regimen/sequence of treatment regimens

    Time frame: Up to 8 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

An Observational Cohort Study of Treatment Patterns and Outcomes in Patients With HER2 Positive (HER2+) Metastatic Breast Cancer (SystHERs Registry (Systemic Therapies for HER2+ Metastatic Breast Cancer Study)).

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2012
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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