Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer in Asia (MADELINE ASIA)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, multicenter study

Study drug and medical condition

• Medicinal product name:
  IBRANCE
• Study drug International non-proprietary name (INN) or common name:
  PALBOCICLIB
• Medical condition to be studied:
  Breast cancer

Population studied

• Short description of the study population:
  The study population included patients aged 18 years or older diagnosed with advanced or metastatic breast cancer received treatment with palbociclib.; Inclusion Criteria:; 1. Owns or has regular access to an Apple iPhone (version 5.0 or higher with latest software: iOS 9.0 or higher) or Android phone (eg, Nexus or Galaxy with latest software: version 4.4.2 or higher).; 2. Adult women (≥18 years of age) with diagnosis with advanced or metastatic breast cancer not amenable to resection or radiation therapy with curative intent.; 3. Documented evidence of HR+ tumor based on the patient’s most recent tumor biopsy.; 4. Documented evidence of an HER2– tumor based on the patient’s most recent tumor biopsy. HER2– is determined as an immunohistochemistry score of 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio <2 or, for single probe assessment, a HER2 copy number <4).; 5. Initiating first, second or third line treatment with one of the following therapies: palbociclib and an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with advanced or metastatic disease as per label, or palbociclib with fulvestrant if the patient has experienced disease progression following endocrine therapy as per label, or other approved therapy as the first treatment for advanced or metastatic breast cancer, or initiating other approved therapy as the second or third treatment for ABC or mBC.; 6. Evidence of a personally signed and dated informed consent form document indicating that the patient has been informed of all pertinent aspects of the study.; 7. Able to read and understand English or Mandarin Chinese .; 8. Willing and able to complete data entry via smart phone (iphone or android) mobile app.; ; Exclusion Criteria; 1. Patient is initiating neoadjuvant systemic therapy.; 2. In the judgment of the investigator, the patient’s life expectancy is fewer than 3 months at the time of diagnosis of ABC or mBC.; 3. The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study.; 4. The patient is on active treatment for other malignancies other than ABC or mBC.; 5. Patient eligibility should be reviewed, documented, and confirmed by an appropriately qualified member of the investigator’s study team before patients are enrolled in 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:
  Patients with advanced or metastatic breast cancer
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The primary objectives of this prospective non-interventional study (NIS) are to assess and describe patient-reported outcomes (PROs) in women with locally advanced/unresectable or metastatic (ABC/mBC) HR+/HER2– breast cancer receiving: IBRANCE in combination with Aromatase inhibitor or fulvestrant as per product label
• Data analysis plan:
  Descriptive analyses only, no hypotheses being tested