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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
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.
详细描述
In Brazil, breast cancer is the most common carcinoma in women, non- melanoma skin carcinomas. 66,280 new cases of breast cancer were estimated for each year of the 2020-2022 triennium, which represents 29.7% 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 75.2% (73.9 - 76.5) 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Start of first-line treatment from 2019
排除标准
- •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
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 2 years
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.
次要结局
- Overall Survival (OS)(2 years)
- Cost-effectiveness analysis (CEA)(2 years)
- EQ-5D questionnaire(2 years)