Bridging Gaps in Breast Cancer Research

Dr. Jose Pablo Leone’s Vision for Clinical Trials in Male Breast Cancer

At the Dana-Farber Cancer Institute, Dr. Jose Pablo Leone is championing a critical shift in oncology: building clinical trials that aim to improve outcomes for men with breast cancer. Speaking passionately about his ongoing research, Leone articulates a bold vision for trials that address historical gaps in representation. “We’re working hard to design trials that aim to improve outcomes for men with breast cancer” said Dr. Leone.

His work underscores a growing recognition that clinical research in men with breast cancer is not optional—it is essential.

Redefining Clinical Trials for Real-World Impact

Dr. Leone began by acknowledging a long-standing challenge in cancer research: clinical trials often fail to represent the full spectrum of patients affected by disease.

“One of the biggest problems in our field is that the evidence we generate doesn’t always apply to everyone,” he explained. “We tend to focus on the majority populations, but we need to think about how our therapies work across all patient groups—including those with rare cancers.”

His current trial, spearheaded at Dana-Farber, seeks to address this imbalance by focusing on men with new diagnosis of breast cancer.

“Our goal is to collect data that helps us understand what are the best endocrine therapy options for men with breast cancer” said Leone. “We cannot make meaningful advances for all patients unless we generate data that reflects all patients.”

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Focusing on Male Breast Cancer: A Rare But Urgent Priority

Leone also acknowledged the psychological and cultural challenges male patients face. “Many men don’t even realize they can get breast cancer, and when they do, they often feel isolated. Our trial offers them not only access to cutting-edge treatment but also a chance to be represented in the science.”

To be continued

Click to enlarge RETHINKING MALE BREAST CANCER DIAGNOSTICS By: Robert Bard, MD While mammography remains a conventional screening tool, it is rarely used in men unless they present with symptoms such as breast enlargement, nipple discharge, or palpable masses—particularly in those with a BRCA gene mutation. More often, practitioners now rely on ultrasound as the primary imaging modality for male breast evaluation. This includes the use of advanced Doppler to assess vascular activity, which can help distinguish benign growths from malignancies. Common benign findings such as gynecomastia—especially in adolescent and young adult males—are readily identified with ultrasound. Fatty tumors like lipomas also appear clearly using this modality. However, the diagnostic power of ultrasound becomes critical when suspicious symptoms present, such as subareolar masses, nipple retraction, or bloody discharge. In such cases, ultrasound can quickly detect the presence, size, and structure of the tumor and guide further intervention.  (See complete report)

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Designing for Accessibility and Representation

Dr. Leone stressed that good participation requires more than just opening enrollment. His team has implemented proactive measures to engage patients who might otherwise be excluded due to geography, disease characteristics, or comorbidities. “We’ve partnered with community clinics and advocacy organizations to reach patients where they are,” he explained.

This patient-centered design reflects Leone’s broader philosophy: clinical trials must adapt to patient needs, not the other way around.

Innovations in Trial Design and Data Collection

In addition to expanding access, Dr. Leone’s trial incorporates innovative methodologies to improve the quality and relevance of its findings. This includes the use of patient-reported outcomes, which can offer nuanced insights into how treatments impact patients’ lives daily.

“By capturing patient experiences directly, we’re getting a richer picture of efficacy and tolerability,” Leone explained. “We need to know not just whether a drug works, but how it impacts quality of life—something especially important for male patients who may have different psychosocial dynamics.”

Leone’s trial also leverages advanced imaging and biomarker analysis to explore potential differences in tumor biology between men and women. “We’re still learning about how male breast cancer may behave differently,” he said. “Our goal is to use every tool available to uncover those differences and translate them into better care.”

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A Call for Cultural Change in Research

Courtesy of: Gary Elroy/ MBC survivor

Dr. Leone concluded his remarks with a call to action for the research community. “We need a cultural shift in how we think about clinical trials,” he urged. “Representation isn’t just a checkbox—it’s the foundation for scientific rigor and ethical responsibility.” Leone said. “We owe it to our patients to ensure that every group sees themselves reflected in the science that guides their care.”

Conclusion: Building a New Standard of Care

Dr. Jose Pablo Leone’s clinical trial is more than an academic endeavor; it is a blueprint for a future in cancer research. By deliberately addressing gaps in representation and accessibility, Leone is setting a precedent for trials that better serve all patients—male and female, common and rare diagnoses alike.

At Dana-Farber, this work underscores a broader mission to make cutting-edge therapies accessible to every person facing a cancer diagnosis. As Leone’s trial progresses, it promises not only to generate vital data for male breast cancer but also to inspire a new paradigm where no patient is left out of the pursuit for cures.

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AFTERMATH

“A Wake-Up Call for Gender-Specific Cancer Care” By Robert L. Bard, MD – Chair of Clinical Diagnostics, MBCGA

As a diagnostic imaging specialist, I have spent decades studying the pathways of cancer—how it develops, how it spreads, and most importantly, how it responds to treatment across diverse patient populations. This work has exposed a critical flaw in our system: despite clear biological differences, men and women are too often treated as interchangeable in cancer care.

What Dr. Jose Pablo Leone is accomplishing with the ETHAN trial is groundbreaking because it directly challenges this outdated paradigm. For decades, endocrine therapies were designed and tested almost exclusively in women, then applied to male breast cancer patients with minimal data. This has led to unpredictable outcomes and, in many cases, severe and unnecessary toxicities.

In my role with the Male Breast Cancer Global Alliance, I’ve met countless male patients who suffer debilitating side effects from therapies never optimized for their physiology. Men metabolize drugs differently, and their hormonal environment—characterized by higher androgen levels—alters both efficacy and tolerability. For example, aromatase inhibitors in men without gonadal suppression may fail to achieve sufficient estrogen blockade, while tamoxifen often produces more profound sexual dysfunction and thrombotic risks. These are not minor variations; they are fundamental biological differences that demand tailored solutions.

The ETHAN trial embraces this challenge by investigating endocrine strategies specifically in male breast cancer, including the use of gonadal suppression and CDK4/6 inhibitors. It gives us a chance to understand not only which treatments control tumors but which minimize collateral damage to quality of life—a factor too often sidelined in oncology.

It’s time for a cultural and scientific shift. Gender-specific research must become the standard, not the exception. ETHAN stands as a model of how we can advance precision medicine and equity simultaneously. It reminds us that treating men based on female-centric data is no longer acceptable in a field striving for excellence. We owe every patient—not just the majority—the dignity of evidence-based care.

For more information about the MALE BREAST CANCER GLOBAL ALLIANCE PREDISPOSITION TESTING PROGRAM, contact us at: www.mbcglobalalliance.org or contact our hotline at: 516.522-0777

“DROP THE BIAS” is the campaign and battle cry of the Male Breast Cancer Global Alliance—a bold call to end the harmful misconception that breast cancer is a “women-only” disease. This bias in medicine, media, and society creates dangerous blind spots in care, leaving men misdiagnosed, undertreated, or ignored. It limits access to screening, support, and survivor recognition. But bias also lives within—men often avoid seeking help out of fear, stigma, or shame. “DROP THE BIAS” confronts this cultural and clinical oversight head-on, urging the world to recognize that men get breast cancer too. The campaign is not just about awareness—it’s about action. By challenging outdated assumptions, educating providers, empowering survivors, and opening dialogue, the Alliance aims to rewrite the narrative and save lives. “DROP THE BIAS” is a mission, a movement, and a message to all: equity in cancer care starts with truth.

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THIS MESSAGE IS BROUGHT TO YOU BY THE MALE BREAST CANCER GLOBAL ALLIANCE

The Male Breast Cancer Global Alliance (MBCGA) is leading the charge in awareness, education, and support for men affected by this disease. This organization has built a worldwide network of survivors, advocates, researchers, and healthcare professionals working to shatter the stigma and silence surrounding male breast cancer. They’ve played a crucial role in pushing for more inclusive research, advancing public health messaging, and ensuring men have access to the resources they need. Through tireless advocacy and collaboration, MBCGA has helped get male breast cancer recognized in global cancer policy and has elevated the voices of countless survivors. Their data-driven campaigns and survivor-led storytelling have reached millions, and their partnership with Bard Diagnostics is all about scaling that impact through accessible genetic testing.

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RELATED RESOURCES

Under a dedicated partnership with the Male Breast Cancer Global Alliance, BARDDIAGNOSTICS established key programs including: EARLIER DETECTION, PREDISPOSITION GENE TESTING, FIGHT RECURRENCE, ACTIVE SURVEILLANCE AND THE 2ND OPINION SCAN. For the many MEN who seek a significantly improved lifestyle or an upgrade in personalized healthcare, getting better answers about your state of health is paramount and IT ALL STARTS WITH STATE OF THE ART DIAGNOSTICS. The visionary paradigm that makes up true personalized medical care involves the integration between modalities, a collaboration between specialists and an upgrade in their strategic approach and you'll find it all at BardDiagnostics. 

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UNCOVERED – Shedding Light on Male Breast Cancer
The first official newsletter from the Male Breast Cancer Global Alliance, launched in proud partnership with AngioMedical Media and the Integrative Cancer Resource Society. Rooted in the belief that education is power, UNCOVERED delivers essential news, scientific updates, and survivor stories to inform and inspire. Each issue is packed with the latest in male breast cancer research, treatment innovations, and advocacy efforts from around the globe. Whether you're a patient, caregiver, or medical professional, UNCOVERED is your trusted source for facts and forward-thinking perspectives. Join us in uncovering the truth—and empowering lives through knowledge. (visit our regularly updated Newsletter)

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The INTEGRATIVE CANCER RESOURCE SOCIETY is a self-funded (Linkedin Based) independent volunteer group of non-profit foundations/charities, researchers, educators, community leaders and survivors. Under the spirit of collaboration and partnership, we are joined to bring a new level of support to cancer patients, survivors and all those seeking current information about cancer care. We form a unique network of support for one another- while driven to help those who need additional resources, technical updates or empowerment on the road to recovery. ICRS uses the power of the "interweb" to reach a global audience and a network of resources beyond our local borders. We have engaged some of the most impressive minds, perspectives and resources and enjoyed the exchange of vital information that is useful to all. Thanks in part to digital collaboration, these "foreign" connections have always been a part of our cancer crusade, now joining us in what we call "BORDERLESS MEDICINE".

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In great support of a the global movement of NON-INVASIVE medicine, we proudly introduce the INTEGRATIVE HEALTH RESEARCH CENTER by AngioInnovation Research (501c3). This New York city-based diagnostic imaging validation lab is established to clinically identify the efficacy, performance and supportive claims set by non-invasive therapeutics and diagnostic solutions. Co-founded by Dr. Robert L. Bard, the IHRC offers a non-profit, non-commercialized testing option for health-related innovations who seek an independent and impartial reporting through single-case pilot studies or IRB-Based clinical trials. The IHRC employs credentialed medical professionals and specialists in clinical research whose experience contributes to the unique strategic approach of each test study. (Visit: the AngioInstitute website)

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