A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastat… (NCT06311383) | Clinical Trial Compass
CompletedNot Applicable
A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
Germany2,610 participantsStarted 2017-10-09
Plain-language summary
This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy
Who can participate
Age range18 Years – 100 Years
SexFEMALE
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Inclusion Criteria:
* Patients with a histological diagnosis of locally advanced/metastatic HR+/HER2- breast cancer. Histological diagnosis does not necessarily origin from metastasis, but must reflect the most recent disease status
* No prior systemic treatment for locally advanced/metastatic disease in the palliative setting
* The treating physician has made the decision to treat the patient
* with ribociclib in combination with an aromatase inhibitor or fulvestrant as initial treatment in first line, or
* endocrine therapy as initial treatment in first line (e.g. letrozole, anastrozole, fulvestrant), or
* chemotherapy as initial treatment in first line (e.g. taxanes, capecitabine, with or without bevacizumab)
* Written informed consent of the patient
* Patient who initiated treatment for first line no longer than 4 weeks (28 days) prior to written informed consent for this study
* Planned treatment is in line with the respective current German SmPC ("Summary of product characteristics")
* Patient is ≥18 years
Exclusion Criteria:
* Patients unable to provide written informed consent
* Contra-indication according to the respective current German SmPC ("Summary of product characteristics"), as judged by the treating physician
* The patient is currently under active treatment in an investigational study