Clinical trial · Observational
Observational Study on the Treatment of Patients With Metastatic Breast Cancer
Real World Outcomes and Treatment Patterns in Brazilian Patients With Hormone Receptor Positive / HER2-negative Unresectable or Metastatic Breast Cancer
NCT06676436CI-TRIAL-00115664REALNESScompletedClinicalTrials.gov clinicaltrialsProvenance
- 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 descriptive, retrospective, observational study to generate Real-World Evidence (RWE). This study will evaluate the treatment patterns and outcomes with metastatic or unresectable hormone receptor-positive breast cancer in Brazil. No hypotheses will be tested.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients by drug class and treatment line
- timeFrame
- through study completion, an average of 1 year"
- description
- The proportion of HR-positive/HER2-negative patients receiving each drug class in each line of treatment
Secondary outcomes (2)
- measure
- Indicate demographic of these patients
- timeFrame
- through study completion, an average of 1 year"
- description
- Demographic profile: age, gender, ethnicity, family history of BC
- measure
- Indicate pathological characteristics of these patients
- timeFrame
- through study completion, an average of 1 year"
- description
- Clinic-pathological profile: ECOG, staging, histological type, sites of metastasis, genetic alterations, early breast cancer treatments, comorbidities, menopausal status, description of HER2 testing
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC; * Adult female or male patients ≥18 years old; * Unresectable or metastatic breast cancer; Estrogen Receptor ≥ 1% at the moment first-line treatment was initiated, either in a biopsy immediately before starting treatment for metastatic disease or in the biopsy of initial breast cancer diagnosis if a new biopsy was not performed; * HER2-negative (IHC 0, 1+ or 2+/ISH negative) at the moment first-line treatment was initiated, either in a biopsy immediately before starting treatment for metastatic disease or in the biopsy of initial breast cancer diagnosis if a new biopsy was not performed; * Have received treatment with a CDK4/6i in the first-line treatment for unresectable or metastatic breast cancer; * Have discontinued permanently the treatment with CDK4/6 for any reason: progressed disease on first-line treatment, died during first-line treatment due to any cause, or interrupted treatment for any reason; * Patients with recurrent disease are not mandated to have a new biopsy at the time of recurrence Exclusion Criteria: \- Patients with recurrent disease with a primary tumor showing a different pattern of receptors (i.e. initial BC other than ER ≥ 1% and HER2 negative (IHC 0, 1+ or 2+/ISH negative); * Patients with a concomitant cancer at the time of the diagnosis of MBC HR-positive HER2-negative except for the non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HR-positive HER2-negative BC diagnosis; * Patients who at time of data collection for this study are participating or have participated in an interventional study that remains blinded.
References
Publications (0)
Data not yet available
No reference posted for this study.