Observational prospective study in post-menopausal women with advanced HR+/HER2- breast cancer treated with a combination of Afinitor® + exemestane to describe the management of two Adverse Events, non-infectious lung disease and stomatitis (TANGO)

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

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

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Post-menopausal women (≥ 18-year-old) with metastatic or locally advanced HR+/HER2- breast cancer, for whom the physician decided to initiate Afinitor® + exemestane treatment under their EMA labels.; Inclusion criteria; Patients were consecutively included in each centre if the answer to all of the following statements was ‘yes’:; 1. Post-menopausal women (≥ 18-year-old) with advanced HR+/HER2- breast cancer.; 2. Patients for whom it was decided to initiate Afinitor® + exemestane treatment under their EMA labels.; 3. Patients informed and having provided their consent to participate in the study.; Exclusion criteria; Patients with any of the following criteria were not included:; 1. Patients previously or currently treated with a mTOR inhibitor.; 2. Patients having a contra-indication to Afinitor® treatment as specified in the SmPC.; 3. Patients already participating in a clinical study at inclusion.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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 patients
• Estimated number of subjects:
  639

Study design details

• Main study objective:
  To describe the patterns of management for stomatitis and non-infectious lung disease (therapeutic classes, specific management)
• Outcomes:
  The primary objective assessment of this observational study is to describe the management of two specific AEs, stomatitis and non-infectious lung disease (prescribed treatments: therapeutic class, specific actions taken), for post-menopausal women with advanced ER+ / HER2- breast cancer. Characteristics of stomatitis and non-infectious lung diseasePrevious treatments administered for metastatic disease:Adjuvant hormonal therapy : type, treatment duration, time to recurrence.Afinitor® + exemestane:Overall duration of Afinitor® from first dose until discontinuation or end-of-study.Sequential therapies prescribed after stop of Afinitor® and/or exemestane
• Data analysis plan:
  The statistical analysis plan will be written by the CRO in charge of the study and will be validated by Novartis Pharma S.A.S. prior to performing the analysis.Quantitative variables will be presented in terms of mean, standard deviation, median and extreme values, and in terms of absolute frequency and percentage by modality for qualitative variables. 95% confidence intervals will be presented.All patients included in the study will be analyzed. The reference population for the analysis will be the patients included having available monitoring data relating to Afinitor® + exemestane treatment (monitoring visit, AE / SAE data or end-of-study form). Analyses will be performed using SAS® software version 9.2 or higher.