Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05559528
Status:
RECRUITING
Last Update Posted:
2022-09-29
First Post:
2022-09-26
Brief Title:
BRaziLian outcomE for metAStatic breasT Cancer
Sponsor:
Hospital do Coracao
Organization:
Hospital do Coracao
Study Overview
Official Title:
Clinical Outcomes of Breast Cancer and Its Relation With Access to Health Care in Brazil a Prospective Study in HER2-negativeHormone Receptor-Positive Metastatic Disease
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREAST
Brief Summary:
Given the certain benefit in efficacy of adding CDK 46 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 46 inhibitors
Detailed Description:
In Brazil breast cancer is the most common carcinoma in women non- melanoma skin carcinomas 66280 new cases of breast cancer were estimated for each year of the 2020-2022 triennium which represents 297 of all cancers It is the main cause of cancer death in women and mortality rates remain high due to the large number of cases diagnosed in advanced stages around 40
According to data from Concord-3 five-year survival estimates in the country were 752 739 - 765 for the period from 2010 to 2014 However the 5-year survival rate in the same period was over 85 in 25 countries and reached approximately 90 in North America and Oceania 3 The survival rate in low- and middle-income countries is remarkably different
This disparity in survival reflects the unequal access of the population to breast screening difficulty in diagnosis delayed treatment and limited access to first-line systemic therapy for advanced and metastatic tumors
Notwithstanding with the development of new expensive drugs breast cancer survival differences between Brazil and high-income countries may increase if the access to new agents is not assured
One of the most important changes in the hormone positive breast cancer recently identified was the greatly increased function of proteins that stimulate cells to grow and multiply known as CDK4 and 6 Cyclin-Dependent Kinase These are normal parts of the human cell but in this type of tumor they work much faster than they should making the tumor grow
Recent studies showed benefit with new target therapies that lower recurrence and progression as cyclin-dependent kinases 4 and 6 CDK 46 inhibitors with endocrine therapies in hormone receptor HR-positive human epidermal growth factor receptor 2 HER2- negative advanced breast cancer has shown substantial improvements in progression- free survival PFS
Palbociclib IBRANCE is a first-in-class oral inhibitor of cyclin-dependent kinases 4 and 6 that blocks G1-to S-phase progression There is a strong in-vitro and clinical evidence suggesting that the dual inhibition of CDK 46 and ER signaling is a highly effective therapeutic strategy in HR MBC In the phase 2 PALOMA-1 trial the addition of palbociclib to letrozole significantly improved progression-free survival in women with advanced estrogen receptor-positive and HER2-negative breast cancer Subsequently in the phase III trial that included postmenopausal patients with metastatic HR-positive HER2-negative breast cancer who had not received prior treatment for advanced disease an improvement in PFS 248 vs 145 months hazard ratio HR 058 95 CI 046-072 and objective response rate ORR 42 vs 35 percent was seen with the combination of palbociclib and letrozole compared with letrozole alone
The National Comprehensive Cancer Network NCCN Panel recommends first line therapy for HR-positive HER2-negative with aromatase inhibitor AI in combination with CDK 46 inhibitor palbociclib ribociclib or abemaciclib in postmenopausal women or premenopausal women receiving ovarian ablation or ovarian function suppression with an LHRH agonist combinations of aromatase inhibitors with CDK 46 inhibitors 8 However the situation is rather different in many countries including Brazil where the population has limited access to these medications
The health system in Brazil is organized in two types of assistance the public system known as Unified Health System SUS where the policies and costs are regulated by the State and a private system where the coverage is regulated by the National Supplementary Health Agency ANS through agreements with health insurance plans Nowadays 75 of the Brazilian population is attended by the public system versus 25 in the Supplementary Health Service
The commercialization of CDK 46 inhibitors was only released in the national territory in 2018 but until nowadays it is not accessible for the majority of patients Of note patients in the public health system do not gain access to this class of drugs and those with private insurances usually settle a lawsuit to obtain the treatment once CDK 46 inhibitors are not covered by the National Supplementary Health Agency
Thus the disparity in the access to these important treatments due to socioeconomic differences probably results in worse outcomes according to health care coverage
According to data from Concord-3 five-year survival estimates in the country were 752 739 - 765 for the period from 2010 to 2014 However the 5-year survival rate in the same period was over 85 in 25 countries and reached approximately 90 in North America and Oceania 3 The survival rate in low- and middle-income countries is remarkably different
This disparity in survival reflects the unequal access of the population to breast screening difficulty in diagnosis delayed treatment and limited access to first-line systemic therapy for advanced and metastatic tumors
Notwithstanding with the development of new expensive drugs breast cancer survival differences between Brazil and high-income countries may increase if the access to new agents is not assured
One of the most important changes in the hormone positive breast cancer recently identified was the greatly increased function of proteins that stimulate cells to grow and multiply known as CDK4 and 6 Cyclin-Dependent Kinase These are normal parts of the human cell but in this type of tumor they work much faster than they should making the tumor grow
Recent studies showed benefit with new target therapies that lower recurrence and progression as cyclin-dependent kinases 4 and 6 CDK 46 inhibitors with endocrine therapies in hormone receptor HR-positive human epidermal growth factor receptor 2 HER2- negative advanced breast cancer has shown substantial improvements in progression- free survival PFS
Palbociclib IBRANCE is a first-in-class oral inhibitor of cyclin-dependent kinases 4 and 6 that blocks G1-to S-phase progression There is a strong in-vitro and clinical evidence suggesting that the dual inhibition of CDK 46 and ER signaling is a highly effective therapeutic strategy in HR MBC In the phase 2 PALOMA-1 trial the addition of palbociclib to letrozole significantly improved progression-free survival in women with advanced estrogen receptor-positive and HER2-negative breast cancer Subsequently in the phase III trial that included postmenopausal patients with metastatic HR-positive HER2-negative breast cancer who had not received prior treatment for advanced disease an improvement in PFS 248 vs 145 months hazard ratio HR 058 95 CI 046-072 and objective response rate ORR 42 vs 35 percent was seen with the combination of palbociclib and letrozole compared with letrozole alone
The National Comprehensive Cancer Network NCCN Panel recommends first line therapy for HR-positive HER2-negative with aromatase inhibitor AI in combination with CDK 46 inhibitor palbociclib ribociclib or abemaciclib in postmenopausal women or premenopausal women receiving ovarian ablation or ovarian function suppression with an LHRH agonist combinations of aromatase inhibitors with CDK 46 inhibitors 8 However the situation is rather different in many countries including Brazil where the population has limited access to these medications
The health system in Brazil is organized in two types of assistance the public system known as Unified Health System SUS where the policies and costs are regulated by the State and a private system where the coverage is regulated by the National Supplementary Health Agency ANS through agreements with health insurance plans Nowadays 75 of the Brazilian population is attended by the public system versus 25 in the Supplementary Health Service
The commercialization of CDK 46 inhibitors was only released in the national territory in 2018 but until nowadays it is not accessible for the majority of patients Of note patients in the public health system do not gain access to this class of drugs and those with private insurances usually settle a lawsuit to obtain the treatment once CDK 46 inhibitors are not covered by the National Supplementary Health Agency
Thus the disparity in the access to these important treatments due to socioeconomic differences probably results in worse outcomes according to health care coverage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None