C50
Conditions
Interventions
Group 1: This descriptive study aims to examine event-related endpoints, quality of life (QoL), and therapy management in patients with aTNBC (advanced, triple-negative breast cancer, inoperable or me
advanced, hormone receptor-positive, HER2-negative breast cancer, inoperable or metastatic) who are treated with SG in routine clinical care in Germany. No predefined hypothesis is being tested.
Upon
Sponsors
Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie e.V. (NOGGO e.V.)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years or older at baseline (before SG initiation) 2. Patients with an unresectable and/or metastatic BC 3. Patients with available information on HR and HER2 status of BC and a confirmed aTNBC or HR+/HER2- aBC 4. Patients who are initiating SG therapy, according to tumor board decision prior to start of SG therapy at one of the participating study sites and the manufacturer’s labeling as below o unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease or unresectable locally advanced or o metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting 5. Patients who sign the informed consent form (ICF) indicate that they understand the purpose of the study and its required procedures and are willing to participate in it
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to SG or to any of the drug’s excipients 2. Women who are pregnant or breastfeeding at enrollment date 3. Patients enrolled in a clinical trial at enrollment date (patients enrolled in a non-interventional trial are not excluded) 4. Patients who had SG treatment prior to enrollment date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe OS in aTNBC and in HR+/HER2- aBC patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe patient-reported QoL in aTNBC and in HR+/HER2- aBC patients 2. To describe SG therapy management (duration of SG treatment, treatment delay, dose reduction, discontinuation, and reason for discontinuation) in aTNBC and in HR+/HER2- aBC patients 3. To describe the management of adverse events (AEs) in aTNBC and in HR+/HER2- aBC patients 4. To describe PFS in aTNBC and in HR+/HER2- aBC patients 5. To describe the time to next treatment (TTNT) in aTNBC and in HR+/HER2- aBC patients 6. To describe BC treatment patterns after SG treatment discontinuation in aTNBC and in HR+/HER2- aBC patients 7. For each of aTNBC and HR+/HER2- aBC cohorts, to describe OS, QoL, PFS, and TTNT considering the following subgroups of interest: o BRCA (BReast CAncer gene) mutation o Line of therapy (aTNBC: 2nd line, >2nd line; HR+/HER2- aBC: 3rd line, >3rd line) o Previous poly ADP-ribose polymerase (PARP) inhibitor therapy o Previous checkpoint therapy | — |
Countries
Germany
Outcome results
None listed