Bridging the Gap in Male Breast Cancer Research Through Inclusive Clinical Trial Strategy

While male breast cancer remains a rarity, its impact cannot be understated. Despite accounting for less than 1% of all breast cancer cases, the American Cancer Society estimates that 2,800 new cases were diagnosed in men in the US in 2023. Yet, the journey for male breast cancer patients is fraught with challenges, often stemming from a lack of awareness and understanding of the disease in male patients. From the drug developer perspective, addressing these challenges requires tailored research and development efforts to improve diagnostics and treatment options specific to male breast cancer.

“One of the primary hurdles lies in early detection. While women are typically vigilant about breast cancer and its warning signs, many men remain unaware of their susceptibility,” explains Lisamarie Burgio, Executive Director and Therapeutic Innovation Lead in Oncology. “Ignoring breast lumps or attributing them to benign causes, men often delay seeking medical attention until the situation becomes dire.” Compounded by societal stigmas and the fear of emasculation, this delay in diagnosis severely impacts treatment outcomes and, ultimately, survival rates, notes Burgio.

Despite these challenges, breast cancer researchers are optimistic that reconsidering their approach to clinical trial enrollment for breast cancer will encourage more diverse participants. Our oncology experts offer three pivotal approaches that oncology development teams can use to create more inclusive trial opportunities.

#1: Reassessing Inclusion/Exclusion Criteria: "In reevaluating the criteria for clinical trials, sponsors have the opportunity to dismantle barriers that hinder male participation,” says Juan Manuel Carrera, MD, Senior Medical Director in Oncology. “More often than not, there is rarely a trial that explicitly excludes male breast cancer patients.” This may involve reevaluating traditional criteria that may inadvertently exclude male participants or creating specific criteria that better reflect the demographics and characteristics of male breast cancer patients. “By acknowledging the unique needs and experiences of male breast cancer patients, sponsors can adapt their criteria to foster inclusivity and encourage male engagement in research endeavors,” adds Carrera.

#2: Partnering with Breast Cancer Advocacy Groups (PAGs): Collaboration with cancer patient advocacy groups can serve as a catalyst for change among willing development teams. Through strategic partnerships, sponsors can amplify awareness, drive community engagement and advocate for the inclusion of male breast cancer patients in clinical trials. For example, at Syneos Health, our oncology trial experts partnered with the Male Breast Cancer Global Alliance (MBGCA) to innovate on ways to enroll more male breast cancer patients. ?“The MBGCA advocates for all men diagnosed with breast cancer to ensure that they receive equal access to support and treatment," says Cheri Ambrose, founder of and president of the MBCGA. "Through our collaboration, male breast cancer patients can be adequately represented in research and clinical trials through the knowledge and experiences of survivors and experts.”

Cross-functional relationships between PAGs and asset developers can facilitate the ability to collect and analyze data and insights from patients, their families and advocacy communities. They can also better inform not only patient recruitment but also protocol design, study endpoint identification to market access, and commercialization strategies.

#3: Leveraging Testimonials and Social Proof: The power of storytelling cannot be underestimated. By sharing testimonials from male breast cancer survivors, sponsors can humanize the research process, fostering empathy and understanding. Furthermore, leveraging social proof serves to validate the unmet needs and opportunities within the male breast cancer community, driving awareness and participation in clinical trials.? For example, in working with the MBCGA, our experts developed social media specifically targeted to male breast cancer patients.

As the life sciences navigate the complexities of breast cancer research, it is imperative that oncology teams adopt a multifaceted approach rooted in inclusivity and collaboration. By embracing these principles and championing change, the industry can pave the way for a future where all breast cancer patients receive the support, treatment and ultimately, the hope they deserve.

Is your team looking for innovative ways to execute oncology clinical trials? Explore our options and contact an oncology-hematology clinical trial specialist today.

Contributors

Lisamarie Burgio, RN | Executive Director, Oncology Therapeutic Innovation and Strategy

Juan Manuel Carrera, MD | Senior Medical Director, Oncology

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