An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16776
• EU PAS number:
  EUPAS3014
• Study ID:
  16776
• Official title and acronym:
  An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a multicenter, prospective OCS designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:•Patients with HER2-normal disease receiving their first cytotoxic chemotherapy and/or targeted therapy (1500 patients)•Patients with HR-positive tumors receiving their first HT for advanced disease (500 patients) Patients who started their first systemic treatment for advanced breast cancer within 1 month prior to enrollment into this OCS will be eligible. A total of approximately 2000 patients will be enrolled. In order to assure that treatment patterns over time are represented in the study, the number of sites activated will be determined by projections to achieve complete enrollment over approximately 18-24 months.
• Study status:
  Planned

Research institutions and networks

Institutions

Marquette General Health System

Study timelines

Date when funding contract was signed

Planned: 01/06/2006

Study start date

Planned: 02/06/2008

Date of final study report

Planned: 02/06/2008

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Genentech

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only