Carcinoma, Ductal, Breast
Conditions
Interventions
This is a two-arm, open-label, randomized controlled clinical trial. Women enrolled in the control group will undergo regular breast cancer screening, with mammography, in accordance with the recommen
Sponsors
Universidade Federal de Goiás
Rede Brasileira de Pesquisa em Câncer de Mama
Eligibility
Sex/Gender
Female
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Participating in the study will be women aged 40 years or older; living in the city of Itaberaí (urban and rural areas); users of the Unified Health System and registered by the Family Health Strategy; who accept to participate in the project and sign the Term of Free and Informed Consent
Exclusion criteria
Exclusion criteria: Women under 40 years of age; with a current or suspected diagnosis of breast cancer or who refuse to collect data or sign an informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast cancer mortality: defined as the number of breast cancer deaths over the number of women at risk, in each group x 100,000. It is expected to find a reduction in the number of deaths in the analyzed period, verified through the mortality registry, with a difference of at least 20% between the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Staging of breast cancer at diagnosis: according to the TNM classification, 8th edition of the American Joint Committee on Cancer – AJCC. It is expected to find a reduction in the number of advanced cases, verified through staging at diagnosis, with a difference of at least 10% between the groups.;Overall Survival: the overall survival time interval will be calculated, starting from the date of the histological diagnosis until the date of closure of the database, being considered as an event the patients who obtained up to that date and as censored patients who are alive until that date. It is expected to find an increase in overall survival, verified through clinical follow-up, with a statistically significant difference.;Disease-Free Survival: the time interval of disease-free survival will be calculated, starting from the date of the histological diagnosis until the date of closure of the database. Patients who relapsed until that date will be considered as an event and patients who are alive and have not relapsed until that date or who died from other causes without recurrence of the disease will be considered as censored. It is expected to find an increase in disease-free survival, verified through clinical follow-up, with a statistically significant difference. ;Cancer-specific survival: the overall survival time interval will be calculated, starting from the date of the histological diagnosis until the date of closure of the database. The death of the patient as a result of the progression of breast cancer up to that date will be considered as an event and patients who are alive up to that date or who died from other causes will be considered as censored. It is expected to find an increase in cancer-specific survival, verified through clinical follow-up, with a statistically significant difference.;Mammographic Coverage: percentage of the ratio of the number of mammograms performed in the target population and the number of women residing in the municipality, | — |
Countries
Brazil
Contacts
Public ContactRuffo Freitas-Junior
Universidade Federal de Goiás
Outcome results
None listed