A PROSPECTIVE, NON-INTERVENTIONAL STUDY ASSESSING THE DIAGNOSTIC, THERAPEUTIC PROCEEDINGS AND SAFETY OF ANTI-HER2 TREATMENT IN ELDERLY PATIENTS (≥70 YEARS OLD) WITH HER2 POSITIVE BREAST CANCER IN ROUTINE CLINICAL PRACTICE IN POLAND -MULTICENTER, OBSERVATIONAL STUDY (HEROLD) (HerOld)

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)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post Authorization Safety Study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TRASTUZUMAB

  PERTUZUMAB
• Medical condition to be studied:
  HER2 positive breast cancer

Population studied

• Short description of the study population:
  The following patients were enrolled into the study: all 70 years or older patients diagnosed with early, locally advanced or metastatic HER2 positive breast cancer who had agreed to participate in this study conducted in local research centers, regardless of the planned therapeutic proceedings.; The target population for this study will be: ; • Elderly postmenopausal women (70 years old or above) diagnosed with HER2- positive breast cancer confirmed by validated immunohistochemistry (IHC) or in situ hybridization (ISH) methods; • The study will enroll patients who are eligible for anti-HER2 therapy as well as patients who were disqualified from anti-HER2 treatment; • Eligible patients scheduled for neoadjuvant, adjuvant or metastatic treatment with Herceptin subcutaneous or intravenous formulation with or without Perjeta IV in realworld settings, according to NHF drug program “Treatment of Breast Cancer” in Poland. Baseline visit and follow up will be planned according to local standards and NHF drug program “Treatment of Breast Cancer” requirements in Poland.; Patients must meet the following criteria for study entry:; • Elderly female postmenopausal patients: ≥70 years of age; • Postmenopausal - defined as at least 60 years of age, having undergone bilateral oophorectomy, medically confirmed ovarian failure or younger than 60 years of age and having had cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and having serum levels of estradiol and follicle stimulating hormone within the laboratory's reference range for postmenopausal females; • Histologically or cytologically confirmed and documented adenocarcinoma of the breast (all breast cancer stages, all patients); • HER2-positive (defined as either IHC3+ or in situ hybridization (ISH) positive) as assessed by local laboratory on primary tumor and/or metastatic site if primary tumor is not available (ISH positivity is defined as ratio of 2.0 or for the n
• Age groups:
  • 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:
  150

Study design details

• Main study objective:
  Primary Objectives - SafetyThe safety objectives of this study pertain to a subgroup consisting of patients ttreated with anti-HER2 treatment (Herceptin SC or Herceptin IV with or without Perjeta IV).
• Outcomes:
  Safety objectives: Frequency of discontinuation of anti-HER2 treatment caused by adverse events (AEs), evaluate safety of anti-HER2 treatment and frequency of AEs, Serious AEs (SAEs), and AEs of special interest (AESIs),frequency of anti-HER2 treatment interruptions, discontinuation, reintroduction, and assess the completion of the assumed treatment plan. Effectiveness Objectives: epidemiological info for included patients, diagnostic proceedings before qualification, anticancer therapies before qualification/disqualification, info for the qualification process and reasons for disqualification, concurrent anticancer therapies, timing/type of surgery/radiotherapy in eBC patients who at start received neoadjuvant anti-HER2 therapy with Herceptin SC.
• Data analysis plan:
  As no formal hypothesis will be tested in this non-interventional study, all analyses will be descriptive in nature. Descriptive statistics will include at least number of subjects, mean, standard deviation, minimum, and maximum for quantitative variables, and frequency and percentage for categorical variables. Additionally, 95% confidence interval will be provided. When relevant, statistical analyses for patients receiving anti-HER2 medication will be carried out by treatment arms of NHF Drug Program “Treatment of the Breast Cancer” as well as stage (early or locally advanced and metastatic breast cancer). Statistical analysis will be carried out by the treatment arm only for the descriptive analysis, no intent to statistically compare Herceptin IV to SC formulation.