A phase IV multicentre, open-label, non-interventional study of postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer treated with Afinitor® (everolimus RAD001) in combination with exemestane, after progression following therapy with a non-steroidal aromatase inhibitor (BOUDICA)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational Study

Study drug and medical condition

• Name of medicine:
  AFINITOR
• Name of medicine, other:
  exemestane
• Medical condition to be studied:
  Breast neoplasm

Population studied

• Short description of the study population:
  The target population of this study was postmenopausal female patients ≥ 18 years of age with ER+ locally advanced or metastatic BC for whom a decision had been taken to initiate treatment with Afinitor® in combination with exemestane. There were no restrictions regarding the last anticancer treatment prior to enrolment. Treatment was not administered for the purpose of inclusion in the NIS, but was given exclusively for the purpose of medical and therapeutic need. Only patients meeting all of the inclusion criteria were invited to enter this study.; Inclusion criteria; Patients eligible for inclusion in this study had to fulfill all of the following criteria:; • Postmenopausal women with ER+ locally advanced or metastatic BC.; • Patients ≥ 18 years of age.; • Prior decision to initiate Afinitor® plus exemestane.; • Provided written and signed informed consent to participate in the study; Exclusion criteria; There were no exclusion criteria except for the contraindications listed in the SmPC. Participating patients were not allowed to take part in any clinical study whilst on Afinitor® plus exemestane, as that would not constitute routine medical practice and would, therefore, counter to the aims of a NIS. On progression, patients could be enrolled onto further clinical studies, which was captured in the electronic case report form (eCRF) until the end of the study.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Breast cancer
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  The primary objective of this study is to describe two specific toxicities, stomatitis and NIP, in patients treated with Afinitor in combination with exemestane for ABC after progression on a NSAI.
• Outcomes:
  The descriptions will comprise incidence, severity, length of time to onset, duration, clinical course, specific management (prophylaxis and intervention) and will look to identify any potential predisposing factors on the likelihood of development. Determine the dosing, schedule and duration of treatment with Afinitor and exemestane, PFS, PRO with EQ-5D and SWB questionnaires
• Data analysis plan:
  All analyses will be performed by Novartis or a contracted designee.Descriptive statistics include n, mean, standard deviation, median and ranges for continuous variables and frequencies and percentages for categorical variables and will be provided unless otherwise specified

Documents

Study results

rad001jgb14--clinical-study-report_Redacted_02 Sep 2019