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Background: It is estimated that 50 thousand patients live with metastatic breast cancer (MBC) in Brazil. A recent Brazilian registry (LACOG 0312) on MBC demonstrated a median overall survival (OS) by breast subtype of 15 months for triple negative, 23 months for HER2 positive, and 42 months for Luminal tumors, which are very similar to developed countries except the HER2 positive group which have limited access to targeted agents in the public health system. Recently, CDK 4/6 inhibitors were approved for the treatment of HR+ HER2-negative MBC with an improvement in progression-free survival (PFS) and ribociclib and abemaciclib demonstrating benefit in OS over endocrine therapy alone, establishing the standard of care in first-line setting for this BC subtype. In Brazil, disparities exist in the incorporation of novel anticancer agents between public and private health systems limiting treatment options for patients with HR+ HER2- negative MBC in the public system, which covers most of the population. The BRAVE study aims to describe the patient journey and current patterns of care for HR+ HER2-negative MBC to identify possible gaps and how health insurance type influences treatment patterns in Brazil. Trial Design: This is an observational, retrospective cohort study. All patients diagnosed with mBC (either de novo or recurrent) in the period of January 2018 to December 2020 at participating centers will be included. Data will be collected from medical records. No interventions are proposed. Enrollment of a total of 300 patients (150 patients from public health care system and 150 patients from private health care system) is planned. ClinicalTrials.gov identifier: NCT05034393. Eligibility: Inclusion criteria: women ≥18 years old; histologically confirmed HR-positive HER2-negative invasive breast cancer; HR-positive, defined as 1% to 100% of tumor nuclei positive for ER and/or PgR as per ASCO/CAP Guideline 2020 or Allred score of ≥3; HER2-negative, defined as IHC result is 0/1+ or 2+ with ISH negative as per ASCO/CAP Guideline 2018; diagnosed with de novo or recurrent metastatic breast cancer between January 2018 and December 2020. Exclusion criteria: male BC; first-line treatment for mBC received through clinical trial. Specific Aims: Primary objective is to describe the first-line (1L) treatment of HR-positive, HER2-negative mBC in Brazil. Secondary objectives are to describe progression-free survival (PFS) in the 1L setting until month 24; describe and compare the 1L treatment of HR-positive, HER2-negative mBC and PFS until month 24 according to the health care coverage (public vs. private); describe timelines from symptoms, histopathological diagnosis, molecular test, and treatment; describe the mBC pathological characterization; describe frequency of diagnostic tests to define breast cancer molecular subtypes; describe the subsequent line of treatment and corresponding PFS; describe overall survival (OS); evaluate PFS and OS according to visceral vs. non-visceral metastatic disease, primary endocrine resistance vs. acquired endocrine resistance, de novo versus recurrent disease, public vs. private health system and pre vs postmenopausal status. Statistical Methods: No a priori sample size calculation was performed. The expected sample size of 150 patients in each group allows description of the proportion of patients using CDK 4/6 inhibitors with two-sided 90% confidence interval ranging from 53.4% to 66.6% when the expected proportion is 60% in the private health system. Present Accrual and Target Accrual: A total of 12 sites of 14 planned were activated. The first patient was enrolled on February 8, 2022. As of June 24, 2022, a total of 122 patients were enrolled, 86 from public and 36 from private health system. The target accrual of 300 patients is expected to be completed by November 2022. Results are expected to be presented by April 2023. Funding: Novartis. Acknowledgements: SAS. Citation Format: Gustavo Werutsky, Tomás Reinert, Daniela D. Rosa, Romualdo Barroso-Sousa, Heloísa Resende, Poliana A. Signorini, Juliana G. Martins Fagundes, Jose Marcio B. Figueiredo, Eduardo Cronemberger, Aline C. Vieira, Jorge Henrique Santos Leal, Luiza Nardin Weis, Ludmila Thommen, Rafaela G. Jesus, Gustavo Gössling, José Bines. Real-World Data on First-line Treatment of HR-positive, HER2-negative, Metastatic Breast Cancer in Brazil (BRAVE Study/LACOG 0221) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-07-01.

Background: Breast Cancer (BC) is one of the most common cancers diagnosed in Li-Fraumeni Syndrome (LFS). Most studies about the frequency of germline pathogenic variant (PV) TP53 p.R337H have been conducted in the South and Southeastern regions of Brazil reaching rates as high as 8% of detection. There is a lack of data on the frequency of this germline PV in other Brazilian regions, especially among patients without access to genetic tests. Objective: This study aims to evaluate the detection rate of TP53 p.R337H in patients (pts) at risk of hereditary breast cancer (HBC) and describe the clinical and demographic profile of the study cohort. Methodology: Hereditary cancer risk assessment based on the National Comprehensive Cancer Network Criteria (NCCN), version 1.2020, was performed in women with BC who were being followed in a public hospital (DF, Brazil) between January 2021 and January 2022. All pts eligible for germline genetic testing according to HBC NCCN criteria were referred for genetic counseling and genetic testing. For those patients who could not afford a comprehensive genetic test, a real time PCR test specifically searching for TP53 p.R337H variant was performed. In case of TP53 p.R337H detection in the proband, genetic counseling and familial variant testing were offered to family members. Results: Among 221 pts eligible for this study, 180 pts performed germline testing, including 100 pts tested only for the TP53 p.R337H variant (real-time PCR) and 80 pts performed out of pocket BC multigene panel testing (including TP53 sequencing). This cohort was mostly represented by pts from Central-West (47%) and Northeast (35%) regions of Brazil. The median age of BC diagnosis was 44 y.o. (18 - 78). Invasive ductal carcinoma represented 92% (n=203) of the tumors, 50% were ER/PR+ HER2-, 25% HER2 +, 25% ER/PR- HER2- (triple negative). Regarding stage at diagnosis, 59% (n=130) were stages IIB-IIIC and 13% IV. The detection rate of TP53 p.R337H was 1.1% (2/180). Among the pts who met the revised Chompret criteria for LFS, this frequency was 5% (2/40). One of them was diagnosed with a stage IIIB IDC ER/PR+HER2- at 28 y.o. and had no relevant family history of cancer. The other pt was diagnosed with a stage IV IDC ER/PR+HER2- at 44 y.o. and the family history revealed four sisters and one niece with BC, and one nephew with brain tumor at 4 y.o. The family members from these two families received genetic counseling and genetic testing. Cascade testing was able to identify 12 additional carriers. All carriers were referred for post-testing follow-up. Conclusion: According to these results, we expect to identify at least one p.R337H carrier in each 90 BC pts treated in the Federal’s District Public Health setting who fulfill HBC NCCN criteria. In a limited resources setting, in Brazil, testing the TP53 p.R337H variant with PCR is a low-cost test that should be considered at least for pts that meet the revised Chompret criteria. The overall detection rate of TP53 p.R337H carriers was lower in comparison to other Brazilian studies from the South/Southeast of the country. Both cases identified in this cohort had advanced local disease or metastatic disease at BC diagnosis, raising the concern about the importance of LFS diagnosis, and high-risk surveillance and risk reduction strategies in this subgroup of pts. Despite the low detection rate of TP53 p.R337H in this cohort, there was a high familial impact through cascade testing. Citation Format: Tatiana S. Correa, Renata L. Sandoval, Eduarda S. Oliveira, Ana Carolina R. Leite, Luiza Nardin Weis, Maria Isabel Achatz, Claudiner P. Oliveira, Paula Fontes Asprino, Romualdo Barroso-Sousa. Frequency of germline TP53 p.R337H variant among women at risk of hereditary breast cancer in a public health system of Central-West of Brazil [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-03-19.

Objective: The lack of financial resources challenges the inclusion of genetic testing in the Brazilian Public Health System. This study aims to describe the detection rate of germline pathogenic variants (GPVs) in patients at risk of hereditary breast cancer (BC) in the public hospitals of Brasilia, DF, as well as the clinical and demographic profile of patients (pts). Methods: Hereditary cancer risk assessment based on the National Comprehensive Cancer Network Criteria, version 1.2020 was performed on patients with a personal history of BC who were being followed in a public hospital (DF) between January 2021 and January 2022. Results: Among 217 female pts eligible for this study, 78 pts performed germline multigene panel testing out of pocket. Panels included 26–84 cancer susceptibility genes. Patients in this cohort were mainly from the center-west (46%) and northeast (31%) of Brazil. The median age of BC diagnosis was 42 years. Invasive ductal carcinoma represented 88% of the tumors. From a total of 78 BC, 52% were hormone receptor-positive, 23% HER2 positive, and 24% triple-negative. Most patients presented with locally advanced disease: 50% (n=39) IIB-IIIC and 8% (n=6) had metastatic disease. The detection rate of GPVs was 20% (n=16). Among these 16 patients, the most frequently mutated genes were BRCA1/2 (n=11, 68.5%) and TP53 (n=2, 12.5%). Conclusion: The overall detection rate of GPVs was similar to other worldwide studies. In comparison with other Brazilian studies, GPVs in TP53 were at lower rates, possibly because this cohort was enriched by patients from Brazilian center-west and northeast. Higher rates of advanced disease at BC diagnosis may impact treatment outcomes. The lack of access to genetic testing in the public health system takes away the opportunity for cancer prevention, more effective treatments, and proper family risk assessment.

Objective: The purpose of this study was to analyze the relationship between obesity and clinical outcomes in breast cancer patients by evaluating the mean body mass index (BMI) and overall survival. Methods: This is a retrospective observational and descriptive study without intervention, carried out in a public oncology service in the Federal District. We selected breast cancer patients with hormonal expression positivity in follow-up from January 2016 to December 2020. Results: In all, 305 female patients were evaluated, aged between 33 and 92 years with a median age of 59 years. Most patients were over 55 years of age (63.3%). The mean weight of the patients was 71.70±9.10 kg. Regarding BMI, 38.7% of patients were classified as obese. As for the immunohistochemical (IHC) classification, 72.9% of the patients were Luminal B. Among the patients in whom the initial treatment was registered, 56.1% received hormone therapy, while 43.9% received chemotherapy. The intention to treat in most patients was curative. Most patients had disease staging between II and III. As for the outcome, most patients were still undergoing treatment (83.0%) at the time of data collection. Correlating the IHC classification with patient survival, there was no significant difference between patients classified as luminal A and those classified as luminal B (p=0.342). There was also no significant difference between non-obese and obese patients in the assessment of overall survival and weight (p=0.917). Conclusion: Despite the high prevalence of obesity in the studied population, the overall survival of this group did not differ from the non-obese group, even in the analysis by IHC profile.