ACORI RESEARCH REVIEW: JULY 2026

A Patient-Centered Approach to Clinical Trial Matching: Metro Minnesota Community Oncology Research Consortium

Finding eligible patients for oncology clinical trials—and identifying appropriate trials for patients, particularly in community settings where most care is delivered—remains one of the most persistent challenges in cancer research and care delivery. For multidisciplinary cancer care teams, trial identification often depends on fragmented systems, manual processes, and limited visibility across institutions, making timely, accurate trial matching difficult in routine care.

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The Metro Minnesota Community Oncology Research Consortium (MMCORC) has sought to address these challenges through the development of a patient-centered clinical trial matching platform, CancerTrialConnect.org, designed to simplify and expand access to trials across its network.

The development of CancerTrialConnect.org represents a shift from clinician-dependent trial identification to a more structured, accessible, and patient-inclusive model. The platform was designed as a Minnesota-based clinical trial navigator, enabling patients and providers to more easily identify potential trial opportunities within the MMCORC network and other institutions.

Unlike traditional trial listings, which often require users to interpret complex eligibility criteria, the platform guides patients through a series of questions where they input key information about their cancer diagnosis, resulting in potential matches for clinical studies. This approach simplifies the discovery process and provides a more intuitive entry point into clinical research participation. It also shifts trial discovery from a provider-driven task to a shared process in which patients can actively participate.

For care teams, the platform serves as a complementary tool that can support conversations about trials earlier in the care continuum. By making opportunities more visible and easier to explain, it helps reduce reliance on informal referral pathways, which can be a barrier for providers.

While CancerTrialConnect.org introduces a digital front end for trial identification, its effectiveness depends on integration with a broader clinical infrastructure. Matching is not fully automated; rather, it is supported by research staff and physicians who confirm eligibility, coordinate referrals, and guide patients through enrollment.

This hybrid approach reflects the realities of oncology care, where trial eligibility often hinges on nuanced clinical factors such as prior treatments, comorbidities, and molecular characteristics. The platform’s role is to identify potential opportunities, while multidisciplinary teams ensure that matches are clinically appropriate and logistically feasible. It can also identify trial options earlier, including atdiagnosis or during treatment planning discussions.

Importantly, the platform aggregates trial information from multiple sites, ensuring that patients are not limited to studies available only within their immediate clinic, expanding access without needing to shift patient care to distant academic centers.

Early Pilot Results and Impact

CancerTrialConnect.org was launched as a pilot initiative on December 15, 2025, and currently features trials for breast and prostate cancers. Approximately 15 patient matches were identified through the platform, and at least 3 patients enrolled in trials who may not have otherwise been matched to those opportunities.

Although modest in scale, these early outcomes highlight how even incremental gains in matching can meaningfully improve trial access and accrual. In practical terms, these results suggest that even a simple, patient-facing navigation tool can uncover otherwise missed enrollment opportunities within existing research programs.

A key advantage of the platform is its ability to increase awareness and usability for both patients and providers. Traditional clinical trial databases can be difficult to navigate, with complex filters and technical language that limit usability—particularly for patients.CancerTrialConnect.org addresses this gap by offering a more accessible, user-friendly experience tailored to real-world needs. For multidisciplinary teams, this translates into more informed patients, more productive discussions about research options, and a greater likelihood that eligible individuals are identified in a timely manner. It also reinforces the role of clinical trials as a standard component of care, rather than a last-resort option.

MMCORC’s experience reflects a shift in how clinical trial matching can be approached by adopting digital navigation tools that engage patients directly. For cancer care networks, improving trial participation does not require complex automation or advanced artificial intelligence. Progress can be achieved through practical, patient-centered platforms that expand access, simplify navigation, and integrate into existing care workflows. As clinical research continues to evolve, platforms like CancerTrialConnect.org demonstrate that effective solutions should align with how care is actually delivered—connecting patients, providers, and research opportunities in ways that are both practical and scalable within the community setting.

About Metro-Minnesota Community Oncology Research Consortium

MMCORC is a nonprofit research program sponsored by the National Cancer Institute and participating hospitals and clinics. This program, which is administered by HealthPartners Institute, provides people in the Minneapolis-St. Paul community with access to the newest therapies available for cancer treatment, management of treatment adverse effects and disease symptoms, and cancer prevention. The overall goal of MMCORC is to bring cancer clinical trials (cancer control, prevention, screening, treatment, and imaging) to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and reduced cancer disparities. For more information, visit mmcorc.org.

Meeting Patients Where They Are: Sanford Health’s Rural Decentralized Clinical Trial Model

For patients with cancer who live in rural communities, participating in a clinical trial can require hours of travel, time away from work and family, and significant logistical coordination. As decentralized clinical trials (DCTs) become more common across oncology research, health systems are exploring how to bring more trial-related activities closer to home while maintainingthe rigor and oversight required for clinical research.

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At Sanford Health, that effort is rooted in geography. As the largest rural health system in the United States, Sanford serves more than 2 million patients across 8 states and 320,000 square miles. While the organization has a robust research enterprise with more than 1100 active studies and trials, many patients live far from the academic and specialty centers where research is traditionally conducted. For these patients, the cost and inconvenience of traveling that distance can become a barrier to participation.

Sanford’s decentralized trial journey began nearly a decade ago, when a physician sought a way to extend clinical trial access to patients in remote communities. What started as employing telemedicine to support patients across multiple sites gradually evolved into a broader effort to reduce travel burden and expand research access across the health system’s footprint.

As interest in decentralized models grew, Sanford recognized that scaling these efforts would require more than individual workarounds. A key step was the development of a comprehensive capability grid that catalogs resources across the organization’s clinics and medical centers. The tool identifies which locations can support activities such as laboratory testing, imaging, infusions, pharmacy services, and telehealth visits, allowing research teams to determine which study components can be completed closer to a patient’s home.

The health system also established a dedicated DCT Navigator role to help coordinate decentralized activities across departments and serve as a resource for investigators, research staff, sponsors, and operational teams. The position reflects Sanford’s recognition that successful implementation requires collaboration among clinical research, regulatory, finance, legal, compliance, and clinical operations teams.

One of the program’s defining characteristics is a willingness to explore solutions rather than immediately dismiss requests that seem challenging. In practice, that may mean arranging local laboratory testing before a study visit, coordinating imaging at a nearby facility, or working with sponsors and external research centers to support patients who are unable to travel. According to program leaders, these experiences have helped identify operational barriers while building internal expertise that can be applied to future studies.

As Sanford continues to develop its program, leaders are focused on creating the policies, governance structures, and workflows needed to support broader adoption. The team is also working to define measures of success, including patient satisfaction, travel miles avoided, and trends in enrollment and retention.

Sanford’s experience highlights many of the questions organizations are now confronting as decentralized approaches move from pilot projects to operational reality. Key considerations include assessing local site capabilities, establishing cross-functional operational support, navigating contracting and billing arrangements, engaging physician champions, and developing meaningful measures of program impact. As decentralized approaches continue to evolve, organizations will need to balance flexibility, patient convenience, and regulatory requirements while building sustainable infrastructure for long-term success.

Smart Patients Platform: Designing Clinical Trial Access Around the Patient Experience

Despite continued expansion of oncology clinical trials across tumor types and treatment settings, meaningful patient enrollment continues to lag behind availability, highlighting a critical disconnect between trial activity and real-world access at the point of care. Providers understand the value of clinical trials. The greater challenge is communicating the role of clinical trials in a way that is meaningful, relevant, and accessible to patients.

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ClinicalTrials.gov has long served as a foundational infrastructure for trial access in the United States. But this website was not designed as a patient-facing platform. Even for highly engaged patients, navigating protocol language, eligibility nuances, and inconsistent formatting can be burdensome or prohibitive. As a result, patients may meet eligibility criteria yet never enroll.Improving trial participation, therefore, requires not just better matching, but better translation—transforming enrollment opportunities into something patients can understand and meaningfully consider.

Smart Patients illustrates how clinical trial access can be reframed through a more patient-centered lens. The platform features 24 cancer types and 24 other conditions, ranging from depression, obesity, and stroke, to Alzheimer disease, Parkinson disease, and more. Patients can search for clinical trials by condition or the National Clinical Trial identification number (NCT), the unique identifier assigned to each study. Search results are intentionally streamlined—highlighting essential elements such as trial phase, sponsor, timeline, and location—before allowing patients to explore a simplified summary of the study, including treatments and eligibility criteria.

By presenting curated trial information in plain language and a structured format, the Smart Patients platform reduces the burden often associated with trial discovery. Rather than requiring patients to interpret dense listings, the focus shifts to clarity:

What the study is assessing
Who it is intended for
What participation may entail
Where it’s available.

For providers, this type of resource can serve as a practical extension of the clinical conversation—reinforcing key points and giving patients a way to revisit information outside of time-constrained office visits.

Beyond Information: The Role of Peer Communities

A distinguishing feature of the Smart Patients model is the emphasis placed on community during the trial discovery process. Patients and caregivers not only access information—they engage with others who face similar situations. The Smart Patients Communities page features 100+ condition-specific communities, from cancer and autoimmune disease to neurologic conditions and caregiving. Patients can deepen their understanding by learning directly from others living with the same condition. It’s also a place for patients to ask questions, share experiences, and have honest conversations with people who understand what they’re going through.

For many patients, the decision to consider a clinical trial is influenced as much by lived experience as by clinical compatibility. Questions about clinical trial logistics, quality of life, reimbursement, time commitment, and expectations often fall outside the scope of traditional discussions with a health care provider, yet those considerations weigh heavily in decision-making. Peer exchange helps fill that gap. It introduces practical context and, equally important, normalizes participation. One patient noted, “I’m committed to sharing my experience with this community to support the trial and contribute to learning.”

For oncology programs, this highlights an important consideration: Patient education does not end at the point of care. It continues through reflection and discussion, and increasingly, that is through digital engagement. As clinical trial matching capabilities continue to mature, particularly within community-based settings, there is an opportunity to build a more cohesive access pathway. Matching tools can efficiently locate relevant trials based on clinical data. However, once a potential match is identified, the process becomes less technical and more human-centered. Patients must weigh the opportunity against personal priorities, perceived burden, and trust in the process.

A key next step is strengthening patient-provider communication with tools that reflect how patients seek, process, and validate information. For cancer care providers, the implications are increasingly pragmatic. As trial portfolios expand, the ability to support patients beyond identification will be essential.

For cancer programs, this may include:

Incorporating accessible trial summaries into patient education materials
Guiding patients to vetted digital resources that reinforce clinical discussions
Recognizing the role of peer insight as a complement to health care provider guidance.

Tools that improve understanding, reinforce conversations, and extend engagement outside the clinic can help programs move from offering trials to truly enabling participation.

Clinical trials will continue to grow in complexity. The systems supporting them should move in the opposite direction—toward greater clarity, accessibility, and patient alignment. The next phase of progress in clinical research will not be driven solely by scientific innovation, but by how effectively that innovation connects with patients. Designing for the patient experience is no longer an enhancement to clinical trial access—it is foundational to ensuring that trials reach the patients they are ultimately designed to serve.

About Smart Patients

Smart Patients is an online community for patients and families affected by a variety of illnesses. With the Smart Patients tool, patients learn at their own pace and comfort level about scientific developments related to their condition, share their questions and concerns with other members, and use what they learn to effectively make decisions about their health. Learn more at smartpatients.com.

ASCO Research Site Self-Assessment for Enrollment in Clinical Trials

Between 2015 and 2021, the FDA approved 82 new cancer therapies, the vast majority of which were studied in clinical trials that failed to adequately represent Black and Hispanic patients. Efforts to improve recruitment of underrepresented populations span a wide range of strategies, but few interventions have helped sites examine their own data and processes regarding trial recruitment. ASCO’s Research Site Self-Assessment for Enrollment in Clinical Trials, developed in partnership with ACCC, is a tool that helps sites identify potential opportunities for improving trial enrollment within their systems.

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The tool consists of a short assessment followed by an action plan to implement changes. Key areas addressed in the assessment include engaging the community and building trust; addressing barriers to site access; demonstrating a commitment from leadership and the site/network; ensuring accessibility of treatment trials; collecting and analyzing data to assess screening, enrollment, and retention; addressing barriers to screening and enrollment; required training to improve communication; and meeting individual participant needs through effective communication and resources.

Each section presents scenarios designed to help sites reflect on the extent to which their existing policies and procedures align with the statement. For example, one statement is “[the] site/network has strategies that demonstrate trustworthiness to people who are eligible to enroll in clinical trials in our community,” and the site would select if this statement is characteristic of [the] site, somewhat characteristic of [the] site, not characteristic of [the] site, or unable to find.

Other statements gauge the sites’ awareness of their own data: “Our site/network collects and evaluates data to identify challenges in trial enrollment and participation, including tools/technology in place to systemically collect, record, and assess data” with answer categories consisting of: collect and evaluate data, at least annually; do not collect and evaluate data;and unable to find. Without a clear understanding of where they stand, sites cannot know where they have to grow.

After the assessment, sites are encouraged to review their findings and formulate an action plan with specific goals to enhance policies and programs pertaining to enrollment of diverse populations. The action plan prompts sites to consider opportunities to improve enrollment, formulate short- and long-term goals, establish concrete steps to achieve these goals, and identify necessary resources and ways to measure success.

A few years ago, ASCO and ACCC published a manuscript evaluating the impact of the self-assessment tool. At the time, the tool was much longer and has since been condensed for widespread use. Sixty-two sites completed the original tool, representing a mix of practice sizes and settings. Approximately 80% of sites found that the assessment identified opportunities for improvement, and 74% recognized its potential to help increase diversity, equity, and inclusion in trials.

Regarding the sites’ findings on their own procedures and data collection, only 2 sites were able to provide all the data requested in the assessment; the majority could not provide data on trial screening, offering, and enrollment by race or ethnicity. Aside from a clear opportunity to strengthen data collection, other opportunities identified using the assessment included establishing organizational policies to ask eligible patients to participate in trials, creating site-specific goals and strategies to increase participation, implementing prescreening procedures to match patients to trials, developing workforce training policies for prescreening patients, and enacting accountability systems for matching patients to trials and obtaining their consent to participate.

Diversity, equity, and inclusion in clinical trials are best addressed from multiple angles. ASCO’s Site Self-Assessment focuses on the study site’s responsibility for diversity. Before a research site can begin making changes to its program, it must first acknowledge which changes are needed. ACCC encourages all study sites to take the self-assessment and conduct the subsequentaction plan for a better understanding of their own strengths and weaknesses.

Developing Clinical Trial Resources by and for Native Populations

American Indian and Alaskan Native (AI/AN) populations are underrepresented in clinical trials due to a complex set of historic and present-day barriers. Past abuses by medical systems have eroded trust, research infrastructure often fails to reach communities in rural areas, and trials are designed without these groups in mind, making outreach for participation feel like an afterthought. The American Indian Cancer Foundation (AICAF), a nonprofit organization that bridges gaps in cancer care for AI/AN people, is tackling these disparities through education and awareness. This Native-led organization has used its deep cultural knowledge, along with input from its community, to design resources that address some of the biggest driving forces behind low participation of AI/AN patients in clinical trials.

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In May 2026, AICAF, in collaboration with the Minnesota Cancer Clinical Trials Network, published the pamphlet Cancer Clinical Trials in Indian Country. Developed in collaboration with AI/AN community members, this resource provides background on the clinical research process, answers frequently asked questions, and addresses common misconceptions, all using language and design elements tailored to this population. The next phase of this project is a flipbook that will expand on these themes and support AI/AN patients in making an informed decision about whether to enroll in a clinical trial.

Wyatt Pickner, Hunkpati Dakota, program director at AICAF, explained that although the specific procedures and language of clinical trials are often misunderstood, research is already embedded in indigenous culture. “This is a process that we’ve done for decades, generations, centuries,” he said. “We’ve always been researchers and scientists, and we’ve always tested medicines and processes to help improve our health and well-being. This isn’t a new concept.” AICAF’s new resources aim to frame clinical trials within this cultural and historical context and describe how they fit into existing values.

For example, many AI/AN cultures are communal rather than individualistic. Pickner described this as a focus on how a person’s actions contribute to their family, community, tribal nation, and society as a whole. AICAF’s new clinical trial resources reflect this value by highlighting how participation in research can benefit others in their community and future generations.

One of the greatest challenges in developing these resources was balancing the need to culturally tailor language and design with the reality of diversity among AI/AN groups. While some communities and tribal nations share common values and practices, language, geography, and beliefs vary widely. One strategy AICAF uses to address and honor these differences is to create clear opportunities for local clinics and other organizations to modify the resource with community-specific details. The design may include blank spaces that can be filled with logos of local organizations and text that can be edited to reflect the group’s language. For example, a past lung cancer resource prompted users to translate the phrase “your breath is sacred” into the appropriate native language for the community they serve before printing and distributing. These small, authentic details help AI/AN patients feel seen and represented by the educational content and are more likely to foster engagement.

While increasing clinical trial awareness among AI/AN communities is an important step to improve representation in research, there is also a lack of understanding from outside researchers. “AICAF’s belief is that our communities already have the knowledge and wisdom to address the problems we’re facing. It’s just that outsiders aren’t asking the right questions,” Pickner said. AICAF advocates for its community members to have a seat at the table from the earliest stages of clinical trial design. When research is developed with the culture, values, and priorities of a specific community in mind, those patients can tell and are more willing to engage.

Pickner expressed that although current clinical trial enrollment is low, that does not necessarily reflect disinterest. It just shows that the status quo—where AI/AN patients are engaged as an afterthought—isn’t working. “We’re very interested in this work, as long as it’s done correctly and appropriately with us, not necessarily for us, and especially if it can be done by us,” he said.

Cassidy’s Help Report on Potential FDA Reform

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The first section addressed the FDA’s review of new applications and evidence. As clinical trial models continue to evolve and decentralized trials grow in popularity, it is important for the FDA to promote policies that support them, enabling more patients to access groundbreaking research. Integral to this is validating the digital health tools used in decentralized trials. Currently, the FDA treats remote patient monitors the same as medical devices, even though they do not share the same inherent risks or functions. Moreover, the FDA may often require digital health tools to be reevaluated from study to study, or even oppose their use for decentralized data collection, even after they have been approved as medical devices. Removing these inconsistencies and redundant processes would allow digital health tools to be more readily adapted for decentralized trials.

Furthermore, implementation of decentralized trials is often complicated by unclear roles and responsibilities among the sponsor, investigator, and site staff. Today, clinical trial regulations are still largely based on traditional trial models where patients are treated at 1primary site, staffed by 1 primary team. Such regulations have typically stipulated that primary investigators must personally conduct or supervise a trial, which is unrealistic for decentralized trials. Decentralized trials call for different regulations that give community-based study sites greater autonomy to oversee trials once they are adequately trained.

The second section of the report focused on the development of cutting-edge and rare disease therapeutics. Although rare diseases account for a small proportion of all health issues in the US, nearly 30 million Americans suffer from a collection of rare diseases, most of which have no treatments. The FDA’s current approval process and frequent use of clinical holds—an order issued to an investigational new drug to delay a clinical trial—in the rare disease space can discourage researchers from pursuing interventions for rare diseases. A few months ago, the FDA implemented a “flexible approach” framework that would ease certain manufacturing requirements for cell and gene therapies, enabling faster drug development. The HELP reform paper emphasizes the need to build upon this momentum.

Next, the report discusses how the FDA can minimize regulatory inefficiencies and promote competitive pricing of biosimilar and generic drugs. Many types of biosimilars must undergo safety and efficacy testing from scratch, as if they were a completely new biologic product, even if they share the characteristics of an existing product (ie, an established biosimilar with a new route of administration). Moreover, the FDA has been slower to support the interchangeability of biosimilar products than it has for generic drugs; further reform in this area would strengthen overall adoption of biosimilars.

Medical devices and health software are additional areas that warrant policy changes in how these tools are regulated and approved. As technologies have advanced, the FDA has struggled to regulate novel and dynamic applications within its traditional framework. For instance, health software that is hosted on a cloud platform is particularly challenging for the FDA to regulate since the manufacturer does not have exclusive control over the software, as it is under the umbrella of a cloud vendor. The use of artificial intelligence (AI) in health care also needs further regulation; at this time, the FDA addresses machine learning but not generative AI, which can have a greater impact on patient care.

Lastly, the white paper touches on the review of food products and highlights how the FDA can improve its current oversight. For most food ingredients, if the manufacturer deems that the ingredient meets Generally Recognized as Safe (GRAS) standards, then it does not need to go through FDA review, though the FDA may choose to rereview the substance at any point. However, very few GRAS-designated substances are reviewed by the FDA, meaning that thousands of ingredients are routinely consumed without updated safety information. Furthermore, regulations regarding genetically engineered foods need to be modernized to align with rapid technological advancements.

Senator Cassidy’s HELP reform paper addresses important recommendations across various areas under the FDA’s domain. Although significant progress has been made in modernizing regulatory processes, there is still a long way to go in this age of rapid innovation and unprecedented technology. As the paper so poignantly summarizes, “Despite this broad mandate and the FDA’s regulatory complexities, the agency can be easily assessed through one question: Is the FDA fulfilling its responsibility of putting American patients and families first?”

Accelerating Trial Activation, Patient Enrollment, and Data Access: Sarah Cannon Research Institute

In a time when drug discovery and therapeutic innovation in oncology are moving at an unprecedented pace, it is essential that the delivery of clinical trials adjusts accordingly to meet this demand and ensure participation is accessible to as many patients as possible. Sarah Cannon Research Institute (SCRI), a community-based oncology research program, is striving to do just that through its proprietary operations model, Accelero.

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Since its launch in the 1990s, the SCRI’s mission has remained the same: to allow more patients access to clinical trials as part of their integrated standard of care. Three decades ago, it was relatively unheard of to run clinical trials in a community oncology practice rather than at an academic medical center. But the statistics then are the same as they are now: About 85% of patients with cancer never make their way to an academic medical center for treatment. They remain in their community with friends, family, and doctors they trust. Furthermore, for a large subset of this group, securing transportation and lodging hours away from home is not feasible. The availability of clinical trials—and therefore, access to the most cutting-edge therapies—must extend to community cancer programs, or else a large portion of the population will be left out of crucial research.

“We have seen tremendous growth and advancement in the oncology drug discovery process,” said Marcy Vallone, senior vice president of Development Innovations at SCRI, “but the drug development process or how we deliver clinical trials hasn’t really changed.” The traditional clinical trial model is fragmented, and, when faced with the demands of modern research, places undue strain on sites, including slow start-up timelines, delayed patient recruitment, and difficulties with receiving timely and high-quality data. Additionally, in community settings in particular, programs often don’t have dedicated time for staff to focus solely on research. As a result, many programs must build research into their normal day-to-day workflows and adapt to multiple systems and processes to log and access trial data.

“Each trial has its own contract research organization [CRO], its own pharma partner, different protocol requirements, and different systems for training and implementation,” explained Vallone. “Our goal is to centralize as much as we can for our sites so that, regardless of which pharma partner we’re working with or which CRO is involved, the process feels seamless, and the site knows which protocol to follow.”

Accelero focuses on 3 key pillars to streamline the delivery of clinical trials and make them easier to integrate into sites’ existing workflows: faster trial activation, faster patient recruitment and enrollment, and faster access to data.

Accelero capitalizes on SCRI’s integrated CRO-site network that simplifies coordination among research institutions, trial investigators, and biopharma partners—and thus, the clinical trial process as a whole. Vallone described SCRI’s CRO as “an extension of our pharma partners and biotech companies with a niche service offering specific to oncology.” With this model in place, the CRO works with pharma partners to optimize clinical trial protocols from the outset, all with the lens of making the study achievable in the community setting, which both reduces start-up timelines and helps deliver studies more efficiently. Once these protocols are developed, studies are shared throughout the Sarah Cannon network to expand access to patients across the US.

To automate data entry and improve data accessibility, Accelero establishes connectivity between the electronic health record (EHR) and electronic data capture (EDC) systems. With burdensome manual data entry the norm at many community programs, the risk of errors is high. This, in turn, leads to data queries, monitoring, and an overall higher administrative burden on staff. By seamlessly integrating data between the EHR and EDC, Accelero ensures secure, compliant data handling, improves data quality, and delivers it to stakeholders much more quickly.

In the last 2 years, since the Accelero model was launched, SCRI has seen encouraging differentiation in its key performance indicators for study activation and enrollment timelines. Vallone shared that SCRI has seen a 19% conversion rate in oncology patients enrolling in clinical trials, compared to the industry average of 7%. She also cited a 2- to 3-day turnaround time for data transfer from the EHR to EDC, markedly faster than the industry expectation of 10 days.

Vallone commented, “As the largest community-based oncology network in the US, we come to work every day feeling this large responsibility to continue to push our industry partners to think about how we deliver clinical trials differently.” Undoubtedly, the future of clinical trials will depend on organizations such as the SCRI, which strive to continuously improve both the research process and its availability to the 85% of patients with cancer who depend on the care their community centers provide.

A Spotlight on ASCENT‑05 in Advancing Adjuvant Treatment for Early-Stage High-Risk Triple‑Negative Breast Cancer

ASCENT‑05 (NCT05633654) is a phase 3, randomized, open‑label study evaluating whether adjuvant treatment of sacituzumab govitecanin combination with immunotherapy can improve outcomes in patients with early‑stage triple‑negative breast cancer (TNBC) who have residual invasive disease after neoadjuvant therapy and surgery. Patients enrolled in this study are randomly assigned to receive either sacituzumab govitecan plus pembrolizumab or physician’s choice of pembrolizumab alone or pembrolizumab in combination with capecitabine.

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The primary end point of ASCENT‑05 is invasive disease‑free survival. The trial is designed to enroll approximately 1500 patients worldwide.

ASCENT‑05, also known as AFT‑65 OptimICE‑RD/GBG 119/NSABP B‑63, is currently recruiting and represents an important effort to improve adjuvant treatment strategies for patients with TNBC who do not achieve a pathologic complete response with neoadjuvant therapy, with the goal of reducing recurrence risk while maintaining an acceptable safety profile.

For any questions about the trial, please contact the clinical team at mailto:GileadClinicalTrials@gilead.com.

For more information to share with patients, please have them visit:

https://www.ascent05.com/.