A Prospective and Retrospective Observational Study of Real-World Treatment Patterns in Patients with HER2+Advanced or Metastatic Breast Cancer in Europe and the United States

Trial description: Rationale: There is a paucity of real-world data on the current treatment patterns of human epidermal growth factor receptor 2 positive (HER2+) locally advanced breast cancer (LABC) or metastatic breast cancer (MBC) in the European Union (EU) and the United States (US) after the introduction of trastuzumab emtansine (T-DM1) and other new treatments for HER2+ LABC/MBC. This study will describe current treatment patterns and outcomes among patients with HER2+ LABC/MBC and the utilisation of healthcare resources associated with them. This valuable information will improve the current understanding of the treatment paradigm and treatment outcomes of patients with HER2+ LABC/MBC through the introduction of newly approved anti- human epidermal growth factor receptor 2 (HER2) treatments such as T-DM1 and pertuzumab. The study will also illustrate how physicians sequence therapy within the metastatic treatment setting. These data will support local market access and reimbursement negotiations and will provide valuable insight into real-world exposure and adherence to current regimens, and improve the understanding of the reasons for discontinuation of these therapies.Objectives: The objectives of this study are as follows:Primary Objectives:1. To describe treatment patterns for first-, second-, third-, and fourth-line treatments for HER2+ LABC/MBC among patients who have advanced to third-line treatment along with the patients and clinical characteristics associated with receipt of specific treatment patterns.2. To describe the effectiveness, in terms of progression-free survival (PFS), and time to progression (TTP), related to current treatments for HER2+ LABC/MBC. In addition, to identify poor responders to treatment (progression within 6 months of starting any line of treatment) and describe the effectiveness of treatments for HER2+ LABC/MBC in this patient population for all lines of treatment.Secondary Objectives:1. Describe patient’s health-related quality of life during the third and fourth lines of treatment for HER2+ LABC/MBC.2. Assess the tolerability of and adherence to current treatment regimens for HER2+ LABC/MBC, including discontinuation of treatment due to side effects.3. Assess the incidence and treatment of brain metastases in patients with HER2+ MBC.4. Assess healthcare resource utilisation during the third and fourth lines of treatment for HER2+ LABC/MBC by patients with HER2+ LABC/MBC.Data on each objective will be provided both on a region (EU, US) and country level.Study Design:This study will be a multicentre, non-interventional study combining data collection from retrospective chart review and prospective observation of treatment patterns and outcomes for HER2+ LABC/MBC in Europe and the United States.Participating centres will identify from medical records all patients who are entering third-line treatment for LABC/MBC. Information on first- and second-line treatments will be collected using retrospective chart reviews. Data on third-and fourth-line treatments and outcomes will then be collected prospectively for 1 year.It is planned to capture data on approximately 1050 patients with HER2+ LABC/MBC in approximately 150 centres in Europe (Belgium, France, Germany, Greece, Italy, and the United Kingdom) and the US.The Enrollment Period (from the date of the first patient enroled to the date of the last patient enroled) will be approximately 15 months in duration, which will allow a sufficient number of months to identify the desired sample of 1050 patients. Each individual patient will be followed up for 1 year after enrolment. The Follow-up Period (from the start of follow-up for the first patient to the end of follow-up for the last patient) will be approximately 27 months in duration, which allows all eligible patients to contribute up to 12 months of follow-up time.Each patient will contribute follow-up time from the date they begin third-line treatment for LABC/MBC during the Enrolment Period up until death, loss to follow-up (before the last day of the Prospective Follow-up Period), withdrawal of informed consent or the end of the Prospective Follow-up Period.