Breast Cancer Treatment with Afinitor® (Everolimus) and Exemestane for HR+ Women (BRAWO)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

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

Study drug and medical condition

• Name of medicine:
  AFINITOR
• Medical condition to be studied:
  Breast cancer metastatic

Population studied

• Short description of the study population:
  Postmenopausal women with advanced breast cancer previously treated with a nonsteroidal aromatase inhibitor and currently being treated with Afinitor® in accordance with routine practice and the Summary of Product Characteristics.
• 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 metastatic patients
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The aim of this NIS is to acquire information from routine care• on the impact of physical activity on efficacy and quality of life, • on prophylaxis and management of stomatitis in routine clinical practice• on the sequence of treatmentin the treatment of patients with advanced or metastatic HR+ breast cancer who are treated on-label with Afinitor® und exemestane. AEs will be documented.
• Outcomes:
  Primary Observation Parameters: Efficacy of combination of Afinitor® and exemestane in routine use and in relation to intensity of physical activity. Quality of life and physical activityDrug use and treatment sequenceStomatitis managementDocumentation of adverse events
• Data analysis plan:
  Variables measured to be analysed using epidemiology methods with primary use of descriptive statistical methods. If inferential statistical methods are used their results are considered to be purely descriptive. In this exploratory context, no alpha adjustments in multiple statistical comparisons are made.Variables reaching at least interval level will be presented in tabular form including their sample values (no of valid and missing values, min, max, 5th and 95% percentile, first and third quartile, median, mean, standard deviation). For variables at nominal and ordinal level, distribution of the absolute and relative frequencies will be indicated.For adverse events, incidences will be reported based on the patient population included and incidence density (number of events/sum of person times in years) according to the MedDRA system organ class and preferred term for adverse events. Times of events and survival time analyses will be analysed using the Kaplan-Meier methodology.

Documents

Study results

2018-11-16_CSR_BRAWO Final Report Redacted