Introduction: Evolution of a Paper Topic

When selected as an Alamo Advocate Scholar by the Alamo Breast Cancer Foundation to attend the 2025 San Antonio Breast Cancer Symposium (SABCS), I knew I’d be writing a paper on a topic of importance to Inflammatory Breast Cancer (IBC) patients (including patients, thrivers, and survivors (collectively “IBC patients” for this paper)).

This is not the topic I thought I’d be writing on. But the evolution of topic shows the importance of IBC patients, participating in clinical trials, as well as the continuing need for IBC education.

I had initially planned to write on any IBC-specific sessions at this year’s SABCS. Unfortunately, there were no sessions at this year’s conference specific to IBC.¹ From a clinical education perspective, this was unfortunate but not unusual. Far too many IBC patients are impacted by a lack of clinical education about diagnosing and treating IBC.² IBC clinicians, researchers, and patient advocates, including me, have been gathering to try to increase the percentage of patients receiving standard of care by way of the institution-agnostic IBC Community Connect (“IBCCC”). This included the opportunity of attending a late-breaking IBCCC meeting at SABCS this year, where we discussed possible solutions and next steps, such as checklists for patients and institutions.

In the absence of an IBC-specific SABCS session, the alternate plan was to focus on a general breast cancer topic that held particular interest for IBC patients. The status of liquid biopsies seemed promising – online IBC patient forums often discuss liquid biopsies such as Signatera and Guardiant, as well as express confusion over individual differences in whether they are used and what they mean. Liquid biopsies are tests that look for tiny pieces of material tumors may shed in fluids like blood, saliva, or cerebral spinal fluid. Compared to surgical biopsies, liquid biopsies are far less invasive. Additionally, if sufficiently accurate, they could allow monitoring and earlier intervention as to cancer recurrence or progression, as well as risk stratification. Based on the number of abstracts discussing liquid biopsies – and percentage of exhibitors who offered liquid biopsies – there are a number of researchers and companies looking to increase sensitivity and reliability of these tests.

However, early during attendance, I realized that for these technologies to actually help patients, it is not enough that they be accurate and reliable. The big question is, how can these technologies be acted upon in clinics to actually help patients (also known as “clinical utility”)? Without clinical trials on liquid biopsies and on possible therapies in response to results, the answer to what can be done for many patients with these tests is: little to nothing.

One example: even assuming liquid biopsy is sufficiently sensitive to accurately pick up a potential recurrence well before it shows up on radiologic imaging (such as CT, PET or x-ray), there are not yet results from clinical studies that would guide use of this data. That means doctors don’t know whether or how to respond to liquid biopsy data, or even whether the additional lead time helps overall survival. So the current practice remains that distant metastasis cannot be diagnosed or treated without radiologic (imaging) evidence of disease usually followed by a subsequent traditional biopsy. For Stage III IBC patients concerned about IBC’s high rate and speed of recurrence, without clinical studies focused on how to use the data and when or how to respond it, all that liquid biopsies do is give the survivor notice that a recurrence may be coming down the road.³

Thus the remainder of this paper focus on clinical trials, including IBC patient inclusion and IBC-specific data collection. This paper will report on a few current clinical trials presented at SABCS that are particularly relevant to IBC patients – one specific to IBC patients. Because of the historic underfunding of IBC research and exclusion from general breast cancer research, we also need more data about what works specifically for IBC patients. So this paper will also take a look at barriers – individual and systemic – to clinical trial participation by IBC patients and some resources or proposals for overcoming these barriers.

SABCS and Trial Opportunities for IBC Patients

As noted, there were no sessions devoted to IBC at this year’s SABCS. However, SABCS does allow for research to be presented as part of larger sessions and as part of poster sessions, where participants can ask the researchers questions. It was heartening that a search for “Inflammatory Breast Cancer” turned up well over a dozen posters specifically addressing IBC.

This paper will highlight two clinical trials of particular interest to IBC patients.

1. The IBC Clear Study, for IBC patients less than eight months from diagnosis. Head researcher Angela Alexander, Ph.D. attended the conference to speak at this poster session. This IBC-specific study of liquid biopsy (Signatera) looks at results throughout different points in IBC treatment. This is important not only to check the reliability of Signatera (a type of ctDNA liquid biopsy) for detecting minimum residual disease (MRD) in IBC but also potentially providing information on IBC response to treatment at various points and for various patients, providing prognostic information that is more accurate than pathologic complete response, etc. This study was impressive in reducing a number of patient barriers to participation in the study (see the General Barriers section below). It is a multi-center MRD registry for IBC patients, so travel is not needed, and the IBC patient can participate with their own medical team. Moreover, it addresses cost: for patients whose insurance companies will not cover Signatera, they may be able to get Signatera testing for free. Finally, it is accessible: IBC patients can sign up directly or have their doctors sign them up, as preferred. For more information or to enroll: https://clinicaltrials.gov/study/NCT06966050
2. The CLEVER Trial and its successors. An education session on dormancy discussed this results of this Phase II (i.e., smaller-trial) study. The study focused on ways to target dormant cancer cells (measured via disseminated tumor cells in the bone marrow) with readily available drugs, after active treatment is finished but before the cells potentially reactivate and cause a recurrence. This is highly relevant to IBC patients, particularly Stage III patients, who are usually waiting for the other shoe to drop while fervently hoping there are no more shoes. After the session, I emailed the main CLEVER trial investigator, Dr. Angela DeMichele, for more information about the trial. Specifically, I asked whether they anticipated a larger, Phase III trial, if there was a way I could help get IBC patients involved, etc. I received an email back and will be speaking with their clinical team further about the status of CLEVER, as well as two other MRD studies currently enrolling patients: PENN-SURMOUNT and PALAVY (which has opened at multiple centers). More information will follow soon. In the meantime, see, e.g., Penn Medicine September 2, 2025 article summarizing CLEVER and related studies at https://www.pennmedicine.org/news/pioneering-strategy-may-keep-breast-cancer- from-coming-back.

IBC-Specific Barriers to Inclusion in Clinical Trials

Historically, IBC patients were excluded from clinical trials on breast cancer therapies. (See, e.g., Takahashi, supra.) Sometimes this was inadvertent – IBC had previously been excluded and trial designers were using older, boilerplate language when it came to exclusion. And sometimes it may not have been inadvertent. Given IBC patients’ historically worse outcomes and given that there is often a motive in getting the best possible results to ensure drug approval and manufacture, the hypothesis that IBC patients were excluded because they skewed results downwards cannot be ruled out.

When I asked the FDA oncologist panel questions about IBC inclusion in clinical trials during the Alamo FDA Q&A session this year, they confirmed that they have been strongly encouraging inclusion of historically underrepresented groups, including IBC patients and male breast cancer patients. Likely as a result, anecdotally I’ve noticed that fewer current trials exclude IBC patients.

Of course, there will be studies which IBC patients are ineligible because the treatment therein deviates from the current IBC standard of care. (That’s another good reason to continue to also support research that focuses on IBC.) Or IBC patients cannot enroll in time given the expedited treatment IBC requires. Short of these exceptions, however, there is no legitimate reason to exclude IBC patients from clinical trials. Besides thanking the FDA for the push for inclusion (which I did during my question to the FDA panel), there is at least one easy way that IBC patients can push for inclusion. (See action items below, especially number 4.)

Also, as FDA oncologist Dr. Tatiana Prowell observed in response to my question to the Alamo FDA panel about gathering IBC-specific information, IBC inclusion in general trials may be necessary but not sufficient. If only one or two IBC patients are included in each trial and/or if there’s no way to gather data that is specific to IBC patients, inclusion is not as helpful as it could be. We need significant numbers of IBC patients participating, as well as a way to collect IBC-specific data to help make up for exclusion in the past. IBC studies deserve our support as well. However, less than 1% of breast cancer funding is spent on IBC research, despite the fact that IBC patients account for 10% of all breast cancer mortality. That means that in addition to IBC-specific trials, we need to be in broader breast cancer studies and be able to gather IBC- specific data.

Trial design practices and regulations are highly specialized areas, about which I hope to continue to learn more. During the conference, I asked questions of those with more knowledge, including the FDA panel; pharmaceutical representatives; and researchers about how we could get IBC-patient-specific data from these broader trials.

Here are some possible options for gathering IBC-specific data from general clinical studies:

1. At the time of trial design, include IBC patients as a separate cohort
2. Urge pharmaceutical companies to do after-market studies of IBC patients
3. Consider a registry where IBC patients or their doctors can report when they are in a general breast cancer clinical study and report their outcomes.

General Barriers to Patient Participation in Clinical Trials and Resources for Overcoming Them

Unfortunately, there are a number of barriers that can keep patients in general from participating in clinical trials. The three that I learned more about at SABCS include patient fear; cost in money and time; and difficulty in locating relevant studies.

At the Alamo Advocate Program dinner, I learned that patient myths persist about clinical trials. Some fear is understandable because of mistrust sown from poorly done or even unethical trials done many years ago. However, the amount of modern oversight of trials and ensuring informed consent remain extremely high. So today’s clinical trials potentially expand – and definitely do not restrict – treatment options for patients. And they are not only for patients who have no other choice.

Regarding costs, some insured patients do not realize that if treatment during a clinical trial is part of standard of care, insurance will cover the cost. And yet cost can be a real concern – high co-pays, not to mention potential travel costs. One resource is Lindsay’s Legacy Fund, which specifically assists IBC patients with travel and treatment costs. More good news is that the Alamo FDA panel reported that the FDA is now strongly encouraging clinical trials to take place in multiple sites or even allow virtual participation when appropriate. As mentioned above, IBC Clear is an excellent example of a study whose design encourages patient participation and makes it as easy and affordable as possible.

The last barrier that several breast cancer advocates noted at the conference was the challenge of learning about clinical trials in the first place. Most of the time, it takes patient research to learn about trials. And of course patients do not always have the bandwidth, especially during expedited treatment such as with IBC. However, one patient advocate on an Alamo panel mentioned that after active treatment, she had been in over ten studies, primarily by using the search function on the database at ClinicalTrials.gov. As an IBC-specific resource, IBC patient advocate Staci Roe has participated in multiple clinical trials.

Call for Action

In closing, here are some ways that the IBC patient community can make sure we’re counted.

1. Support funding for scientific research generally and ask your loved ones to support it as well. That could include letters to representatives when cuts to cancer research are being considered.
2. Support funding for IBC-specific research in particular, and ask your loved ones and friends to support it as well. That could involve donating and/or volunteering to organizations, especially those that consistently spend most of incoming funds on IBC research.
3. Stay in touch with the IBC patient community, non-profits, and IBC patient advocates, online and/or at in-person meet-ups, to hear about studies and to support each other in enrolling in them.
4. Ask questions of people recruiting for clinical trials, especially pharmaceutical companies. Specifically, ask if IBC patients are included or excluded. If included, thank them and consider signing up for the clinical trial. If excluded, politely ask why this is so. (I asked this of one representative who said they did not have statistics on recurrence for IBC patients, and she gave me her email so I could give her this information. Significantly, she also noted I was not the first person to ask this during the conference – strength in numbers!)
5. If time and effort allow, periodically check ClinicalTrials.gov and share in IBC forums.
6. Consider becoming an IBC patient advocate. One good place to start is with the IBC Network Foundation’s online IBC Learning Academy at https://ibclearningacademy.org/.

Personal Statement

It was an honor to attend SABCS this year as an Alamo Advocate Scholar. In doing so, I picked up a new advocacy goal – to make sure IBC patients can and will access clinical trials and be counted. Additionally, I learned so much by attending an excellent slate of Alamo programs, both before and during SABC; met a number of dedicated breast cancer advocates; and benefitted from the support of AAP mentor Maria Boyce, a top-notch breast cancer advocate and survivor of triple-negative cancer (another traditionally-overlooked type). Thanks also go t to Terry Arnold of the IBC Network Foundation. Among her steadfast support of my patient advocacy work, she was the first to acquaint me with SABCS and the Alamo Advocate Program, then wrote a very kind letter supporting my application.

This paper will be shared in online IBC patient forums, with an executive summary to accompany it. It will also be disseminated to IBC non-profits, including international non-profits, for dissemination to their communities. Another result is that now one of my lasting advocacy goals is to ensure IBC patients can and will access clinical trials and be counted.

---

¹There was one session this year on rare breast cancer. While the written description mentioned only phyllodes tumors and metaplastic breast cancer, I learned after the fact that IBC was touched upon. Upon review of the session video, IBC patient advocate Ginny Mason shared updates about the IBC scoring system and diagnostic codes. This information, while already known to the majority of the IBC patient community, is a welcome from the perspective of IBC clinical education.

² IBC can progress from Stage III (the earliest stage it is detected) to Stage IV in weeks or months, yet one study showed more than one-third of IBC patients face diagnostic error, usually leading to delay in treatment. (Takahashi, Yoko et al. “Inflammatory breast cancer, best practice in the community setting.” NPJ breast cancer vol. 11,1 52. 7 Jun. 2025.) Additionally, adherence to standards of care for treating Stage III IBC appears to be decreasing recently; this is possibly due to the general trend of de-escalating treatment, which is laudable for general breast cancer in general but is not supported by evidence for IBC patients. (Woodward WA. “Deescalation Perils in Inflammatory Breast Cancer.” JAMA Netw Open. 2025;8(2):e2454513..)

³ At least one e-Poster discussed a smaller study on liquid biopsy monitoring in postoperative HR+ IBC. (Uphadhyay, Ranjan). The good news is that it showed that ultrasensitive ctDNA tests can detect minimum residual disease which in turn can predict recurrence. The bad news is that, as explained above, there is nothing that can be done right now with this data for patients. Ultimately, it may help lay the foundation for de-escalation of IBC patients or perhaps show clinical utility once clinical studies show how to react to this information. But more clinical trials are obviously necessary.