Clinical Breast Cancer Research Research Articles

High-value breast cancer care within resource limitations.

Breast cancer care is a costly global health issue where effective management depends on early detection and treatment. A breast cancer diagnosis can result in financial catastrophe especially in low- and middle-income countries (LMIC). Large inequities in breast cancer care are observed and represent a global challenge to caregivers and patients. Strategies to improve early diagnosis include awareness and clinical breast examination in LMIC, and screening in high-income countries (HIC). The use of clinical guidelines for the management of breast cancer is needed. Adapted guidelines from HIC can address disparities in populations with limited resources. Locally developed strategies still provide effective guidance in improving survival. Integrated practice units (IPU) with timely multidisciplinary breast care conferences and patient navigators are required to achieve high-value, personalized breast cancer management in HIC as well as LMIC. Breast cancer patient care should include a quality of life evaluation using ideally patient-reported outcomes (PROM) and experience measurements (PREM). Evaluation of breast cancer outcomes must include the financial cost of delivered care. The resulting value perspective should guide resource allocation and program priorities. The value of care must be improved by translating the findings of social and economic research into practice and resolving systemic inequity in clinical breast cancer research. Cancer survivorship programs must be put in place everywhere. The treatment of patients with metastatic breast cancer must require more attention in the future, especially in LMIC.

Abstract PO3-09-07: When We Tri(al): Reaching, Motivating, & Effectively Engaging Black Women In Breast Cancer Clinical Trial Research

Abstract According to the American Cancer Society, Black women in the United States are 41% more likely to die from breast cancer than non-Hispanic white women. A systematic review of participation in clinical trials found that Black patients comprised less than 4% of all patients enrolled in clinical trials for emerging immune-based cancer treatments. The physiology of Black women has not been a significant consideration in clinical trial research. Clinical trial education, recruiting, and participation are not commensurate with the burden of disease. TOUCH, The Black Breast Cancer Alliance (TOUCHBBCA) launched the When We Tri(al) Movement (WWT) in January 2022 with robust multi-media support and nationwide community event activations to educate and empower Black women with culturally-agile messaging from the trusted voices of Black Breast Cancer survivor/thrivers. WWT provides an innovative and engaging learning platform that clearly depicts how clinical trials work, explains standard of care, dispels historical myths, establishes trust, and empowers self-advocacy. To date, whenwetrial.org has garnered over 108,000 visits and sent nearly 11,000 Black women to clinical trial portals. One-third of unique website visitors have gone into clinical trial search portals. Over a sixteen day period in late June and early July of 2023, TOUCHBBCA conducted research among Black women who joined the When We Tri(al) movement using a pre-experimental, retrospective pre-then-post test (RPTP) survey design to assess growth in knowledge and behavior change among Black women exposed to the Movement. This survey received 113 respondents who self-identified as Black and assigned female at birth. Following exposure to WWT, 34.5% of respondents reported an increase in their understanding of how breast cancer clinical trials work, 31.9% reported an increase in their understanding of standard of care in breast cancer clinical trials, and 40.7% reported an increased understanding of why clinical trials are important for Black women. 32.7% of survey respondents were more likely to consider participating in a clinical trial after interacting with the WWT movement. After interacting with the movement, 31% of respondents took active steps to participate in a clinical trial—specified as searching for clinical trials in a portal, asking about clinical trial options, talking to a doctor about clinical trials, etc. Another 17.7% of respondents reported supporting a loved one in taking steps to participate in a clinical trial only after interacting with WWT. The majority of respondents reported first hearing about WWT through social media (59.2%), followed by “Other” (the majority of write-in responses named Google or a friend) (19.5%). Respondents reported that the most convincing WWT messages were delivered via social media (26.6%) and in-person conversations (20.4%). Not only is When We Tri(al) educating and equipping Black women with critical clinical trial knowledge, but the movement is driving significant behavior change by Black women around clinical trial participation. Citation Format: Ricki Fairley, Emily Powers, Hayley Brown. When We Tri(al): Reaching, Motivating, & Effectively Engaging Black Women In Breast Cancer Clinical Trial Research [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-09-07.

Abstract PO5-11-12: The use of wearable sensors and patient-reported outcomes in breast cancer research: A literature survey

Abstract Background: Clinical outcome assessments (COAs) related to physical activity, sleep, and functional mobility (gait and balance) are common in breast cancer research as they provide insight into treatment effects and overall quality of life. Wearable sensors offer utility in supplementing traditional COAs by providing objective data by passive, continuous measurement, thereby gaining unique insight on functioning while reducing patient burden. However, a comprehensive understanding of how wearables are being used in breast cancer research and how they correlate with subjective measurement of functioning is lacking. Our aim was to identify how wearable sensors and patient-reported outcomes (PROs) are being utilized in breast cancer research, the common areas of overlap, as well as areas in which expanded use of wearable sensors may be beneficial in clinical breast cancer research. Methods: We conducted a non-systematic survey of breast cancer literature using electronic databases (PubMed, Web of Science, Elsevier and Clinicaltrials.gov) to identify oncology trials using both wearable sensors and PROs. Details such as PROs used, types of sensors used, and the data collected from these were extracted and summarized. There were no restrictions placed on the date and year of publication. Results: A total of 15 breast cancer studies, which used both wearable sensors and PROs to measure patient outcomes, were included in analysis. Accelerometers were implemented most frequently in the studies analyzed (73%) followed by pedometers (40%). The most common outcomes measured using wearable sensors were physical activity (47%) and sleep (47%), with only 1 study (7%) measuring functional mobility(gait and balance). The most common outcomes measured using PROs were sleep (47%), followed by quality of life (40%), physical activity (33%), and “other” parameters (40%; e.g., mood, fatigue, pain). Correlation between PRO and sensor metrics were sparce (20%), yet sensor measures of physical activity, sleep, and gait/balance correlated respectively with PROs of activity, sleep, and quality of life. Conclusions: Sleep, quality of life, and physical activity were the most common outcomes measured by PROs, while physical activity and sleep were the most common outcomes captured using wearable sensors. These results suggest there is alignment in outcomes gathered from wearable sensors and PROs, however additional insight may be gained by incorporating wearable sensors for assessment of functional mobility (e.g. walk or balance tests) as these areas are known to impact quality of life in cancer patients and cancer survivors. Further, few studies analyzed correlations between the two measurement systems, suggesting a greater need in understanding how objective measures via wearable sensors and subjective measurements relate. Citation Format: Kelly Dumais, Adam Jagodinsky, Saima Khakwani, Rebecca Bonaker, Bryan McDowell, Kristen Sowalsky. The use of wearable sensors and patient-reported outcomes in breast cancer research: A literature survey [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-11-12.

The future of clinical trials—goals, ideas, and discussion

SummaryClinical trials are subject to an ever-evolving landscape of treatment options, regulatory requirements, socioeconomic conditions, and paradigms of scientific research. In this opinion paper, we illustrate current methods and topics with a focus on clinical trial designs, conduct and modes of collaboration. The example of successful clinical breast cancer research in Austria demonstrates the opportunities, but also the challenges for academic research. We also investigate potential pitfalls, and suggest new ideas and strategies on how to increase practicability along with transparency and fairness, but ultimately also scientific and clinical relevance of clinical trials in oncology.

Abstract 6695: Utility of circulating tumor DNA in breast cancer clinical research and practice: systematic review and meta-analysis

Abstract Background: Circulating tumor DNA (ctDNA) has been increasingly used in the clinical care of patients with cancer. This systematic review summarizes current data on the utility of ctDNA in breast cancer clinical research and practice and provides insights for integrating ctDNA into drug development and patient treatment. Methods: The Embase database was used to identify original clinical research articles of ctDNA in breast cancer published from 2015 to 2020. ctDNA clinical utilities were reviewed and summarized, focusing on 3 areas: early diagnosis, prognostication, and monitoring disease progression/treatment response. Associations of ctDNA with disease-free survival (DFS) and overall survival (OS) were estimated in the embedded meta-analysis. Pooled estimates were calculated using fixed-effect or random-effect models depending on study heterogeneity. Results: After screening and review, 72 articles were included. ctDNA studies have increased in recent years, with 59.7% of included articles published in 2019 or 2020. Overall, 61.1% of the studies were in patients with advanced stage/metastatic cancer; 45.8% were restricted to patients with specific cancer subtypes. ctDNA was minimally used in diagnosis; it was predominantly used in clinical outcome prediction with differences by stage. In patients with early-stage disease, the meta-analyses found that overall ctDNA detection/positivity was associated with shorter DFS (n=697; HR, 5.37; 95% CI, 2.94-9.80) and OS (n=238; HR, 4.60; 95% CI, 2.56-8.26). Specific gene mutations in ctDNA were mainly assessed in patients with advanced/metastatic disease, with mutations of ERBB, ESR1, and TP53 linked to shorter DFS in the meta-analyses (P<0.05). Moreover, current studies provided evidence that ctDNA reflects the dynamics of breast tumors in the patient treatment journey, acting as a biomarker to monitor tumor evolution and drug resistance. Conclusions: Recent studies demonstrate ctDNA application in breast cancer prognostication/monitoring, suggesting an important role in patient stratification, molecular relapse identification, and personalized treatment. Large, multicenter clinical trials and real-world longitudinal data sets are needed to validate findings and to address challenges related to ctDNA to improve clinical utility and to integrate ctDNA testing into clinical practice and drug development. Citation Format: Xuezheng Sun, Nicholas Ballew, Linda Kalilani, Kelesitse Phiri, Kelly Bell, Alexander Slowly, Magdalena Zajac, Erin Hofstatter, Angela Silvestro, Zebin Wang, Jeanne Schilder. Utility of circulating tumor DNA in breast cancer clinical research and practice: systematic review and meta-analysis. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 6695.

Abstract P6-09-03: Examining recollections of Black women with breast cancer who participated in clinical trials: A grounded practical theory study of patient-provider communication

Abstract Introduction: The presence of strong barriers to research participation for Black and Brown women is indisputable. However, existing evidence clearly supports the possibility of equal levels of participation among members of minoritized populations in past breast cancer clinical trials, demonstrating that while these participation barriers do undoubtedly exist, they are not always insurmountable. A main implication of this current study is that researchers should take greater strides to remove the onus of recruitment responsibility from racialized population members, and instead leave it with the providers, investigators, and health care teams who hold enough power to make change. Purpose: This project takes a grounded practical theory (GPT) approach to engage with Black women who have been diagnosed with breast cancer and have participated in a breast cancer clinical trial and explores their recollections of conversations with their providers. GPT focuses on reconstructing particular communication practices, highlighting both the important procedural role of communication in practice and its ability to present intricate complications that echo society’s norms and values. The aim of this work is to investigate and analyze those patient-provider conversations to try to illuminate how providers can better engage these women in ways that will positively influence their perceptions of breast cancer clinical trial participation. Methods: The current study was part of a larger project examining the recruitment of Black women to breast cancer clinical trials. Fourteen women (N=14) from six different states in the U.S., all of whom self-identified as Black, Black American, or African American, agreed to be interviewed as part of a larger study. All participants had participated or were currently participating in a breast cancer clinical trial. The interviews yielded a wealth of interesting and potentially important additional data about Black female breast cancer patients and their communication experiences with their providers. Employing grounded practical theory as a framework helped increase insight into the patient-provider communication needs of Black women who have participated in a breast cancer clinical trial. Results: Findings were summarized into four categories: 1) the participants held differing perspectives and personal impressions toward their providers; 2) the women reflect on their individual breast cancer journeys through richly described incidences, describing searching for, and finding trials on their own, or being guided by healthcare providers who suggested a clinical trial for them; 3) each participant’s shared details of their unique communication relationship with medical and research providers; and 4) the cultural aspects of participants’ patient-provider communication, focusing primarily on their expressions of faith. These findings have important implications for health communication scholars, healthcare providers, and breast cancer clinical trial research principal investigators and team members. Conclusion: As opposed to the conclusion that one may draw from most published explanations of poor minority accrual to clinical trials, which appear to put the blame on the minoritized population members themselves, the current work outlines the actions and non-actions of many providers, and suggests that adjusting to approaches that demonstrate more encouragement and acceptance of their patients might result in better clinical trial participation outcomes from these group members. Citation Format: Precious Okoruwa, Katherine E. Ridley-Merriweather. Examining recollections of Black women with breast cancer who participated in clinical trials: A grounded practical theory study of patient-provider communication [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 P6-09-03.

Abstract P3-04-07: Safety and artifact testing of a nitinol breast biopsy clip in an ultra-high resolution magnetic resonance imaging (MRI) environment

Abstract Background: The lack of safety clearance of several metallic breast implants in 7T(Tesla) poses a significant hurdle to standard clinical breast cancer care and research from reaping the benefits of ultra-high resolution MR imaging. A breast biopsy clip (Ultracor Twirl, Becton, Dickinson and Company, Vernon Hills, IL) composed of nitinol, was tested for safety and artifact susceptibility clearance in a 7T MRI scanner, using standardized procedures. This clearance is significant in henceforth allowing patients with this implant to be scanned in now FDA approved ultra-high-field MRI scanners of 7T or less for clinical and research purposes. Methods: Tests for magnetic susceptibility (torque and translational attraction), MRI-related heating, and artifacts were conducted as per standardized protocols. The torque and translational attraction tests evaluated the effects of magnetic force by the MRI to cause the clip to move and twist respectively. The heating test was conducted with customized MR parameters of short TR (repetition time) and maximum echo-train length, designed to induce temperature change. The artifact test using T1 weighted spin and gradient echo imaging sequences, evaluated potential localized signal loss that may result in misrepresentation of the imaged area. This may occur due to the presence of the metallic clip in the MR environment. Results: The torque and translational attraction tests respectively indicated that the MR environment did not induce any movement in the clip in eight orientations, with a deflection angle of 0 degrees. Results of the heating test indicated no significant temperature change of the clip. A temperature change of less than 0.45C° was observed in the phantom gel in both the absence and presence of the clip, which is well within the safety threshold (< 1°C). Results of the artifact test indicated a very small artifact, with the largest artifact cross-sectional area appearing on gradient echo images. Conclusion: These cumulative results indicate that the Ultracor Twirl breast biopsy clip is safe for imaging patients at 7T. Citation Format: William Dong, Kanchna Ramchandran, Adam Galloy, Marco A. Nino, Marla Kleingartner, Madhavan L. Raghavan, Sneha Phadke, Vincent A. Magnotta. Safety and artifact testing of a nitinol breast biopsy clip in an ultra-high resolution magnetic resonance imaging (MRI) environment [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 P3-04-07.

Abstract OT2-21-01: Assessing Response to neoadjuvant Taxotere and TrAstuzumab in Nigerian women with HER2-positive breast cancer (ARETTA)

Abstract Background: Populations of African ancestry are underrepresented in global oncology clinical trials resulting in paucity of data on safety and efficacy of cancer medicines in vulnerable Black populations. The ARETTA clinical trial was initiated by the Nigerian Breast Cancer Study Team in partnership with the University of Chicago Comprehensive Cancer Center to build local capacity for biomarker informed clinical trials and translational breast cancer research. ARETTA is a pragmatic single-arm, phase II clinical trial to optimize therapy and determine the safety and efficacy of neoadjuvant taxotere and trastuzumab in women with HER2-positive breast cancer. The study sought to 1) determine the pathological complete response (pCR) rate of patients with early stage breast cancer to neoadjuvant docetaxel and subcutaneous trastusumab 2) develop the capacity of investigators in Nigeria to improve quality of care through participation in oncology clinical trials using upgraded facilities and trained personnel and 3) determine accrual rate and retention of participants. Methods: Inclusion criteria include treatment naïve women aged 18 years to 70 years with HER-2 positive breast cancer stages II-IIIC (AJCC). Eligible participants receive four cycles of docetaxel 75mg/m2 and trastuzumab every 3 weeks. Those with incomplete clinical response by breast ultrasound volume measurements receive 3 additional cycles of chemotherapy; cyclophosphamide 600mg/m2, epirubicin 90mg/m2 and 5-fluorouracil 600mg/m2 every 3 weeks before re-evaluation for surgery. All participants receive a fixed dose of sub-cutaneous Herceptin (600mg) every 3 weeks (total of 18 doses). The primary endpoint is pCR rate. Secondary objectives are to evaluate invasive disease-free survival (iDFS), the pattern of response and mechanisms of resistance to treatment based on genomic markers, the pharmacokinetics of Herceptin SC, quality of life, and adverse event rates, including cardiac toxicity. Planned enrollment is 47 evaluable patients, which will provide 90% power to test the null hypothesis that the pCR rate is 20% versus a 40% alternative (one-sided alpha=0.05). More protocol details can be found at ClinicalTRial.gov NCT03879577 and JCO Glob Oncol2020 doi: 10.1200/GO.20.00043 Progress: The study has met its primary endpoint and will be closed to accrual by the time of the meeting. Results will be submitting as Late Breaking before the meeting Citation Format: Atara Ntekim, Adenike Adeniji-Sofoluwe, Abiola Ibraheem, Anthonia Sowunmi, Ayorinde Folasire, Thomas Olajide, Olalekan Olasehinde, Akinwunmi Komolafe, AbdulRazzak Lawal, Foluso Omodele, Ayodele Sanni, Mustapha Ajani, Olayinka Kotila, Sharifat Folorunsho, Tonyin Aniagwu, Adewumi Alabi, Abiodun Popoola, Chioma Asuzu, Adetola Daramola, Chinedum Babalola, Theodore Karrison, Fatimah Abdulkareem, Olufunmilayo I. Olopade. Assessing Response to neoadjuvant Taxotere and TrAstuzumab in Nigerian women with HER2-positive breast cancer (ARETTA) [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 OT2-21-01.

Editorial introductions.

Editorial introductions.

Automated medical chart review for breast cancer outcomes research: a novel natural language processing extraction system

BackgroundManually extracted data points from health records are collated on an institutional, provincial, and national level to facilitate clinical research. However, the labour-intensive clinical chart review process puts an increasing burden on healthcare system budgets. Therefore, an automated information extraction system is needed to ensure the timeliness and scalability of research data.MethodsWe used a dataset of 100 synoptic operative and 100 pathology reports, evenly split into 50 reports in training and test sets for each report type. The training set guided our development of a Natural Language Processing (NLP) extraction pipeline system, which accepts scanned images of operative and pathology reports. The system uses a combination of rule-based and transfer learning methods to extract numeric encodings from text. We also developed visualization tools to compare the manual and automated extractions. The code for this paper was made available on GitHub.ResultsA test set of 50 operative and 50 pathology reports were used to evaluate the extraction accuracies of the NLP pipeline. Gold standard, defined as manual extraction by expert reviewers, yielded accuracies of 90.5% for operative reports and 96.0% for pathology reports, while the NLP system achieved overall 91.9% (operative) and 95.4% (pathology) accuracy. The pipeline successfully extracted outcomes data pertinent to breast cancer tumor characteristics (e.g. presence of invasive carcinoma, size, histologic type), prognostic factors (e.g. number of lymph nodes with micro-metastases and macro-metastases, pathologic stage), and treatment-related variables (e.g. margins, neo-adjuvant treatment, surgical indication) with high accuracy. Out of the 48 variables across operative and pathology codebooks, NLP yielded 43 variables with F-scores of at least 0.90; in comparison, a trained human annotator yielded 44 variables with F-scores of at least 0.90.ConclusionsThe NLP system achieves near-human-level accuracy in both operative and pathology reports using a minimal curated dataset. This system uniquely provides a robust solution for transparent, adaptable, and scalable automation of data extraction from patient health records. It may serve to advance breast cancer clinical research by facilitating collection of vast amounts of valuable health data at a population level.

Editorial introductions.

Editorial introductions.

Role of PI3K/Akt/mTOR pathway in mediating endocrine resistance: concept to clinic.

The majority of breast cancers express the estrogen receptor (ER) and for this group of patients, endocrine therapy is the cornerstone of systemic treatment. However, drug resistance is common and a focus for breast cancer preclinical and clinical research. Over the past 2 decades, the PI3K/Akt/mTOR axis has emerged as an important driver of treatment failure, and inhibitors of mTOR and PI3K are now licensed for the treatment of women with advanced ER-positive breast cancer who have relapsed on first-line hormonal therapy. This review presents the preclinical and clinical data that led to this new treatment paradigm and discusses future directions.

Molecular vulnerabilities and therapeutic resistance in hormone receptor positive and HER2 dependent breast cancer tumours.

Over the past two decades, high sensitivity to HER2-amplified primary breast cancers has been achieved with HER2-targeted therapies. CDK4/6 inhibitors have long been identified as a potential treatment option for advanced breast cancer patients. However, acquired HER2 heterogeneity leading to resistance during the treatment has been identified as a bottleneck. This review focuses on the recent resistance mechanisms identified and potential therapeutic targets for conventional and combination endocrine therapies with CDK4/6 inhibitors by various breast cancer clinical trials and research groups in HER amplified and/or mutated breast cancer tumour. Activating HER2 alterations, JNK pathway, hyperactivated TORC1, co-mutations in HER2 and HER3, phenotypic changes of HER2, and few other advanced findings are identified as potential therapeutic targets in treating current HER2 endocrine therapy-resistant tumour. Along with the HER2-focused resistance mechanisms, we also describe how the microbiome may play a role in breast cancer therapy and its potential for new therapeutic strategies to overcome drug resistance in breast cancers.

In Memoriam: José Baselga's Journey in Cancer Medicine.

In Memoriam: José Baselga's Journey in Cancer Medicine.

Abstract A082: Influencing women's attitudes toward participation in breast cancer clinical research: Improving inclusion of women of color

Abstract The United States is increasingly racially and ethnically diverse. In fact, California is now a majority-minority region, with a greater percentage of its population comprised of racial minorities than whites. Yet, minorities are continually under-represented in clinical research trials, which provide crucial information on which the future of cancer treatments is built. Without representative inclusion of participants of color in clinical research, we cannot develop effective preventative and treatment approaches for everyone. This current study investigates the factors, including characteristics of study consenters, that may influence women—particularly women of color (WOC)—to accept or decline participation in breast cancer-related trials. We assess these factors through a brief survey, administered to patients immediately after they were invited to participate in a breast cancer-related clinical study. From the beginning of study accrual to the present, twenty-three patients have taken the survey. We anticipate accruing 200 participants at a rate of 25 per month. For the preliminary analyses, we split participants in two groups: white women (WW) (n = 14) and women of color (WOC) (n = 9). We conducted independent sample t-tests to compare the responses of WW and WOC. More WOC (M = 1.44, SD = 0.73) reported that it is important that their consenter is of the same ethnicity or race than WW (M = 1.00, SD = .00), t (21) = -2.32, p < .05. Similarly, WOC (M = 1.44, SD = .73) also reported that it is important that the person inviting them to participate in research look like people in their community, compared to the importance placed on this factor by WW (M = 1.00, SD = .00), t (21) = -2.32, p < .05). More WOC (M = 2.33, SD = 1.23) also cited “feeling overwhelmed” with their medical condition as influential in their decision to participate in clinical research than WW (M = 1.31, SD = .48), t (20) = -2.75, p < .05. Although both groups positively rated their interaction with the consenter, we observed marginal differences between WOC and WW. WOC (M = 7.00, SD = .00) gave higher ratings to the variable of “consenter created an atmosphere of trust and support” compared to ratings given by WW (M = 6.29, SD = 1.07), t (21) = -1.99, p = .06. Though participants are generally satisfied with their consenter interaction, different factors influence WW and WOC as they decide whether to participate in clinical research. When identified, these factors can be used to inform more inclusive consenting processes. Citation Format: Noe R. Chavez, Alan Nunez, Angela K. Wong, Tanya A. Chavez, Ellen Rippberger, Christine Thai, Angelica Sanchez, Ombeni M. Idassi, Krista M. Round, Kendall Kennedy, Margarita Robles, Jackelyn A. Alva-Ornelas, Jerneja Tomsic, Chidimma M.K. Kalu, Laura L. Kruper, Veronica C. Jones, Sharon Clancy, Amy C. Polverini, Courtney Vito, Karen Harold, Terry Hyslop, Carola M. Zalles, Daniel B. Schmolze, Christopher Sistrunk, Victoria L. Seewaldt. Influencing women's attitudes toward participation in breast cancer clinical research: Improving inclusion of women of color [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A082.

Abstract A086: Factors influencing women's attitudes toward participation in breast cancer clinical research

Abstract Background: Recruiting participants who are representative of the population as a whole is essential to ensure the development of treatments that benefit all rather than a select few. Understanding the reasons patients accept or decline participation, and then making adjustments to the recruiting process based on these findings, is one way to encourage study participation. Aim: To better understand what factors influence a potential participant's decision to either accept or decline participation in breast cancer trials. Methods: These are preliminary data from a pilot study that uses a short questionnaire to investigate which factors influence a woman's consent or decline to study participation. Women are approached for this study after being asked to participate in one of three other breast cancer trials targeting women who either have breast cancer or are at high risk for breast cancer. Women are approached for this study regardless of their decision to participate in the previous study. Participants are asked a set of questions about 1. the specific interaction they had with the consenter from the previous study, 2. general characteristics of a consenter, and 3. research in general. Demographic information is also collected for future analysis of responses based on race/ethnicity, income, education level, and primary language. Results: A total of 24 participants have completed the questionnaire so far, with an accrual rate of approximately 25 patients per month. Participants ranked the importance of the various factors on a 4-point scale with 1 being “not important at all” and 4 being “very important.” Factors that participants indicated were the least important to their decision to participate were: financial compensation (xÌ… 1.07), racial/ethnic parity between consenter and consentee (\bar x $ 1.19), consenter looking like someone from their community (\bar x $ 1.19), gender parity (\bar x $ 1.19), religious beliefs (\bar x $ 1.38), pleasing their doctor (\bar x $ 1.56), and feeling overwhelmed (\bar x $ 1.85). Factors participants indicated were the most important to them were: the desire to benefit others in the future (\bar x $ 3.63), to benefit their family (\bar x $ 3.56), to acknowledge the contributions of past generations (\bar x $ 3.20), the feeling participation was “the right thing to do” (\bar x $ 3.15), presence or lack of potential side effects associated with participation ((\bar x $ 3.15), feeling empowered by the consenter (\bar x $ 3.15), feeling the consenter was listening (\bar x $ 3.11), and trust in research (\bar x $ 3.07). Conclusions: Concerning the consenter, physical characteristics such as race/ethnicity and gender parity were less important than the actual interaction with the consenter, including their flexibility, listening skills, and ability to make the patient feel empowered. For research in general, the idea of contributing to the “greater good” emerged as a powerful motivation to participate. An emphasis on this, as well as well-trained consenters, may help studies attract more participants. Note: This abstract was not presented at the conference. Citation Format: Ellen Rippberger, Noe Chavez, Tanya Chavez, Christine Thai, Angelica Sanchez, Angela Wong, Karen Herold, Alan Nenez, Krista Rounds, Victoria Seewaldt. Factors influencing women's attitudes toward participation in breast cancer clinical research [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A086.

Aligning the Aligners: Comparison of RNA Sequencing Data Alignment and Gene Expression Quantification Tools for Clinical Breast Cancer Research.

The rapid expansion of transcriptomics and affordability of next-generation sequencing (NGS) technologies generate rocketing amounts of gene expression data across biology and medicine, including cancer research. Concomitantly, many bioinformatics tools were developed to streamline gene expression and quantification. We tested the concordance of NGS RNA sequencing (RNA-seq) analysis outcomes between two predominant programs for read alignment, HISAT2, and STAR, and two most popular programs for quantifying gene expression in NGS experiments, edgeR and DESeq2, using RNA-seq data from breast cancer progression series, which include histologically confirmed normal, early neoplasia, ductal carcinoma in situ and infiltrating ductal carcinoma samples microdissected from formalin fixed, paraffin embedded (FFPE) breast tissue blocks. We identified significant differences in aligners’ performance: HISAT2 was prone to misalign reads to retrogene genomic loci, STAR generated more precise alignments, especially for early neoplasia samples. edgeR and DESeq2 produced similar lists of differentially expressed genes, with edgeR producing more conservative, though shorter, lists of genes. Gene Ontology (GO) enrichment analysis revealed no skewness in significant GO terms identified among differentially expressed genes by edgeR versus DESeq2. As transcriptomics of FFPE samples becomes a vanguard of precision medicine, choice of bioinformatics tools becomes critical for clinical research. Our results indicate that STAR and edgeR are well-suited tools for differential gene expression analysis from FFPE samples.

Development of electronic medical records for clinical and research purposes: the breast cancer module using an implementation framework in a middle income country- Malaysia

BackgroundAdvances in medical domain has led to an increase of clinical data production which offers enhancement opportunities for clinical research sector. In this paper, we propose to expand the scope of Electronic Medical Records in the University Malaya Medical Center (UMMC) using different techniques in establishing interoperability functions between multiple clinical departments involving diagnosis, screening and treatment of breast cancer and building automatic systems for clinical audits as well as for potential data mining to enhance clinical breast cancer research in the future.ResultsQuality Implementation Framework (QIF) was adopted to develop the breast cancer module as part of the in-house EMR system used at UMMC, called i-Pesakit©. The completion of the i-Pesakit© Breast Cancer Module requires management of clinical data electronically, integration of clinical data from multiple internal clinical departments towards setting up of a research focused patient data governance model. The 14 QIF steps were performed in four main phases involved in this study which are (i) initial considerations regarding host setting, (ii) creating structure for implementation, (iii) ongoing structure once implementation begins, and (iv) improving future applications. The architectural framework of the module incorporates both clinical and research needs that comply to the Personal Data Protection Act.ConclusionThe completion of the UMMC i-Pesakit© Breast Cancer Module required populating EMR including management of clinical data access, establishing information technology and research focused governance model and integrating clinical data from multiple internal clinical departments. This multidisciplinary collaboration has enhanced the quality of data capture in clinical service, benefited hospital data monitoring, quality assurance, audit reporting and research data management, as well as a framework for implementing a responsive EMR for a clinical and research organization in a typical middle-income country setting. Future applications include establishing integration with external organization such as the National Registration Department for mortality data, reporting of institutional data for national cancer registry as well as data mining for clinical research. We believe that integration of multiple clinical visit data sources provides a more comprehensive, accurate and real-time update of clinical data to be used for epidemiological studies and audits.

AOJS-6 - Issues and perspectives of drug development from Asia; a view from Singapore in breast cancer trials

Asia is currently one of the most dynamic regions in the world, and offers great promise in the areas of cancer research and drug development. With the rising incidence of breast cancer in many Asian countries, there are opportunities as well as challenges in clinical trials and drug development. Although Asia is often the region of choice for clinical trials in Asian-centric cancers such as EGFR-mutated lung cancers, gastric carcinomas and hepatocellular carcinomas, clinical research in breast cancer is still often dominated by the major centres in the West. One of the key factors which may influence the pharmaceutical companies to consider engaging Asian sites more actively is the discovery of unique features of Asian breast cancers. However, to our knowledge, we have not been able as yet to elucidate any distinctive characteristics of Asian breast cancers, apart from a higher proportion pf premenopausal breast cancers, and among certain ethnic groups, higher frequencies of triple negative breast cancers. The current situation may change with the conduct of large-scale translational research on breast cancer in Asia. Greater interest and support with funding from national authorities and industry partners, as well as increasing academic collaborations, will be essential to achieve this major step forward. As one of the smallest countries in the world, Singapore faces major challenges in the competitive arena of breast cancer clinical trials. Nevertheless, we aim to maximise our strengths to overcome our weaknesses, with regional and international collaborations to play a greater role in breast cancer research.

Extraction of BI-RADS findings from breast ultrasound reports in Chinese using deep learning approaches

BackgroundThe wide adoption of electronic health record systems (EHRs) in hospitals in China has made large amounts of data available for clinical research including breast cancer. Unfortunately, much of detailed clinical information is embedded in clinical narratives e.g., breast radiology reports. The American College of Radiology (ACR) has developed a Breast Imaging Reporting and Data System (BI-RADS) to standardize the clinical findings from breast radiology reports. ObjectivesThis study aims to develop natural language processing (NLP) methods to extract BI-RADS findings from breast ultrasound reports in Chinese, thus to support clinical operation and breast cancer research in China. MethodsWe developed and compared three different types of NLP approaches, including a rule-based method, a traditional machine learning-based method using the Conditional Random Fields (CRF) algorithm, and deep learning-based approaches, to extract all BI-RADS finding categories from breast ultrasound reports in Chinese. ResultsUsing a manually annotated dataset containing 540 reports, our evaluation shows that the deep learning-based method achieved the best F1-score of 0.904, when compared with rule-based and CRF-based approaches (0.848 and 0.881 respectively). ConclusionsThis is the first study that applies deep learning technologies to BI-RADS findings extraction in Chinese breast ultrasound reports, demonstrating its potential on enabling international collaborations on breast cancer research.