Incidence of new Primary Malignancies Among Patients With Bone Metastases From Breast, Prostate, or Lung Cancer Treated With XGEVA or Intravenous Zoledronic Acid: a Retrospective Cohort Study (20170728)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33874
• EU PAS number:
  EUPAS25381
• Study ID:
  33874
• Official title and acronym:
  Incidence of new Primary Malignancies Among Patients With Bone Metastases From Breast, Prostate, or Lung Cancer Treated With XGEVA or Intravenous Zoledronic Acid: a Retrospective Cohort Study (20170728)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study is to estimate the incidence of any new primary malignancy (any haematologic or non-haematologic tumour, excluding non-melanoma skin cancer subsequent to the first primary malignancy) among patients with breast, prostate, or lung cancer and bone metastases following initiation of either XGEVA or zoledronic acid, and to describe the types of new primary malignancies that patients experience, as well as the characteristics of the patients who develop new primary malignancies. The study employs a retrospective cohort design and data from the SEER-Medicare linked datasets.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 13/03/2018

Actual: 13/03/2018

Study start date

Planned: 14/12/2018

Actual: 11/12/2018

Data analysis start date

Planned: 01/03/2019

Actual: 01/03/2019

Date of final study report

Planned: 01/03/2020

Actual: 28/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen, Inc.

Study protocol

Initial protocol

20170728_01.02.06 Public Redacted Protocol Ver 1.0 English

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)