Clinical trial · Observational
BRaziLian outcomE for metAStatic breasT Cancer
Clinical Outcomes of Breast Cancer and Its Relation With Access to Health Care in Brazil: a Prospective Study in HER2-negative/Hormone Receptor-Positive Metastatic Disease
- 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)
Given the certain benefit in efficacy of adding CDK 4/6 inhibitor to first line endocrine therapy in metastatic breast cancer HR+ HER2- , the aim of this project is to evaluate whether patients without private health insurance may have worse outcomes than privately insured women due to limited access to such class of drugs during their treatments. Prospective observational study with 300 patients divided into two groups, one with patients from the public health system and the second with patients treated in the private service. Patients will be recruited in different regions of Brazil and will be followed for 24 months, stratified according to the use or not of the CDK 4/6 inhibitors.
Conditions
Conditions (2)
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 Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Public health system
- description
- Group with patients treated in the public health system in Brazil. They will be stratified according to whether or not CDK 4/6 inhibitors are used in therapy.
- label
- Private health system
- description
- Group with patients treated in the private health system in Brazil. They will be stratified according to whether or not CDK 4/6 inhibitors are used in therapy.
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 2 years
- description
- Progression-free survival (PFS) is the time from the start of treatment to the date of event defined as the first documented progression or death due to any cause. According to RECIST criteria, progressive disease is defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women may be premenopausal or postmenopausal * Metastatic advanced breast cancer * ER-positive and/or PR-positive, HER2-negative tumor * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2 and 3. * Start of first-line treatment from 2019 Exclusion Criteria: * Localized or locally advanced disease * Lack of information about hormonal receptor and HER2 status * Breast cancer in men * Breast cancer in pregnancy * Have progressed from initiation of first-line treatment to study enrollment
References
Publications (1)
- DERIVEDSanvido VM, Pontes LB, Machado RH, Gomes JO, Barbante LG, Nicola ML, Tokunaga SM, Miranda TA, Laranjeira LN, Negrelli KL, Valeis N, Moutinho MSP, Helber HA, Sa RDS, Kawano-Dourado L, Cavalcanti AB, Nazario ACP. Study protocol to assess clinical outcomes of breast cancer and its relationship with access to healthcare in Brazil-BREAST trial (BRaziLian outcomE for metAStatic breasT cancer): a prospective observational study in HER2-negative/hormone receptor-positive metastatic disease. BMJ Open. 2025 Jun 30;15(6):e087877. doi: 10.1136/bmjopen-2024-087877. PMID 40588378