Clinical trial · Observational
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
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 Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor/Fulvestrant, or With Endocrine Therapy or Chemotherapy as First Line Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| First-line chemtherapy | Drug | — | UNRESOLVED |
| First-line endocrine therapy | Drug | — | UNRESOLVED |
| First-line Ribociclib + endocrine therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- First-line Ribociclib + endocrine therapy
- description
- Ribociclib + letrozole, or Ribociclib + anastrozole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
- interventionNames
- Drug: First-line Ribociclib + endocrine therapy
- label
- First-line endocrine therapy
- description
- As of physicians choice
- interventionNames
- Drug: First-line endocrine therapy
- label
- First-line chemotherapy
- description
- As of physicians choice
- interventionNames
- Drug: First-line chemtherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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 studyReferences
Publications (1)
- RESULTDecker T, Brucker C, Engel A, Fasching PA, Gohler T, Jackisch C, Janssen J, Kohler A, Ludtke-Heckenkamp K, Luftner D, Marme F, van Mackelenbergh M, Rautenberg B, Schmidt M, Weide R, Wimberger P, Kisseleff E, Pfister C, Roos C, Wilhelm N, Wockel A. Conditional progression-free survival in patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated with first-line ribociclib and endocrine therapy: real-world data from the RIBANNA study. ESMO Open. 2025 Jun;10(6):105105. doi: 10.1016/j.esmoop.2025.105105. Epub 2025 May 16. PMID 40381382