A PROSPECTIVE, NON-INTERVENTIONAL STUDY ASSESSING THE DIAGNOSTIC, THERAPEUTIC PROCEEDINGS AND SAFETY OF ANTI-HER2 TREATMENT IN ELDERLY PATIENTS (≥70 YEARS OLD) WITH HER2 POSITIVE BREAST CANCER IN ROUTINE CLINICAL PRACTICE IN POLAND -MULTICENTER, OBSERVATIONAL STUDY (HEROLD) (HerOld)

Study identification

• EU PAS number:
  EUPAS24812
• Study ID:
  36953
• Official title and acronym:
  A PROSPECTIVE, NON-INTERVENTIONAL STUDY ASSESSING THE DIAGNOSTIC, THERAPEUTIC PROCEEDINGS AND SAFETY OF ANTI-HER2 TREATMENT IN ELDERLY PATIENTS (≥70 YEARS OLD) WITH HER2 POSITIVE BREAST CANCER IN ROUTINE CLINICAL PRACTICE IN POLAND -MULTICENTER, OBSERVATIONAL STUDY (HEROLD) (HerOld)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  This is a single cohort, observational, local, multicenter, prospective primary data collection, non-interventional Post Authorization Safety Study (NI-PASS). Data from Polish patients diagnosed with HER2-positive breast cancer that are being qualified and treated in NHF Drug Program “Treatment of the Breast Cancer” will be prospectively collected during three-year period (one year of recruitment and up to two years of observation). For patients that failed qualification to NHF Drug Program “Treatment of the Breast Cancer”, reasons for disqualification will be collected and no further observation in the study will take place.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 6 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:20/04/2018

Study start date

Planned:31/07/2018

Actual:17/09/2018

Date of final study report

Planned:30/06/2022

Actual:30/07/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

ML40006