Safety evaluation of biosimilar trastuzumab in breast cancer: Experience of Colombian institutions

Study identification

• EU PAS number:
  EUPAS49290
• Study ID:
  50108
• Official title and acronym:
  Safety evaluation of biosimilar trastuzumab in breast cancer: Experience of Colombian institutions
• DARWIN EU® study:
  No
• Study countries:
  Colombia
• Study description:
  The primary objective is to describe the frequency of adverse events by degree of severity and anatomical group to detail the safety profile of the biosimilar trastuzumab used for breast cancer in Colombian healthcare institutions. A descriptive, retrospective study will be performed on patients treated with biosimilar trastuzumab according to the approved indications for use in breast cancer at the Colombian institutional health service providers (IPS). Data for the study will be collected from the database and clinical records available in the IPS participating in the study, which are reference centers for the management of cancer patients in Colombia. The initial follow-up date will be in October 2019, after approval of sanitary registration. The patient’s index date will be defined as the date of the first infusion of biosimilar trastuzumab. The follow-up time will end when the patient discontinues the treatment, dies, is lost to follow-up or until the end of the collection of information in July 2022. The database and the clinical records of the patients will be the only secondary sources of information. The clinical and treatment variables collected in the study will be recorded in CRF designed for the study. Main variables: Safety profile of biosimilar trastuzumab, Overall survival and progression-free survival, and Tumor response. There is no a priori hypothesis that indicates that sample size calculations can be applied
• Study status:
  Planned

Research institutions and networks

Institutions

Hospital San Ignacio

Study timelines

Date when funding contract was signed

Planned:30/11/2022

Study start date

Planned:05/12/2022

Date of final study report

Planned:31/07/2023

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Pfizer S.A.S, Hospital San Ignacio

Regulatory

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