BREAST
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
Sponsor study identifier
observational
300
1 country
1
Study Start
September 13, 2021
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2021
Actual (reported)September 26, 2022
Actual (reported)September 29, 2022
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Progression-free survival (PFS)
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.
2 years
Overall Survival (OS)
2 years
Cost-effectiveness analysis (CEA)
2 years
EQ-5D questionnaire
2 years
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.
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.
\- Patients with HR+ HER2 metastatic breast cancer divided into two groups: public health system and private service. Patients will be recruited from 20 cancer treatment centers (10 public and 10 private), chosen in different regions of Brazil. We estimate recruiting 20 patients from each private center and 40 patients from each public center, totaling 300 patients in the survey.
Hcor
São Paulo, São Paulo, 04004-030, Brazil
Sanvido 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.
Vanessa M Sanvido, PhD
Hospital do Coracao
Afonso CP Nazário, Professor
Hospital do Coracao
Luciola B Pontes, MD
Hospital do Coracao
First Submitted
September 26, 2022
First Posted
September 29, 2022
Study Start
September 13, 2021
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 29, 2022
Record last verified: 2022-09
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