Breast Cancer CRO
Advancing breast cancer research together
As the most commonly diagnosed cancer in women worldwide, breast cancer presents both urgent challenges and transformative opportunities. At Syneos Health®, we’re committed to accelerating progress in breast cancer research—bringing together clinical and operational expertise to help our customers move with speed, agility and purpose.
From early-stage studies to late-phase and post-marketing research, our fully integrated teams support the full continuum of development. We’ve helped advance therapies across breast cancer subtypes, geographies and study designs, enabling our customers to make a meaningful difference for patients around the world.
Expertise
Experience in the past 5 years in breast cancer clinical trials:
43
clinical studies
>10k
subjects
>2k
sites across a range of product types and MoAs
191
commercial projects spanning many of the top antibody-drug conjugate, targeted therapy and other product brands
Supporting your research across all phases of development and various study types, including:
- Diagnostic studies to improve how breast cancer is detected, characterized and managed in real-world settings
- Therapeutic trials evaluating chemotherapy, targeted agents, immunotherapies, antibody drug conjugates, hormone therapies and combination regimens
- Early stage (adjuvant and neoadjuvant) and metastatic breast cancer programs
- Subtype-specific research, including HER2-positive, hormone receptor–positive and triple-negative breast cancer clinical trials
Why choose Syneos Health for your breast cancer clinical trials?
We meet the unique challenges of breast cancer clinical studies with:
- A site-centered oncology model that fosters deep, collaborative relationships with breast cancer clinical sites, oncology networks like NSABP, key opinion leaders and investigators to accelerate innovation and improve outcomes across the development lifecycle
- Field-dedicated Research Science Liaisons (RSLs) serving as vital connectors that enhance investigator engagement, streamline communication and accelerate breast cancer site enrollment through expert, on-the-ground support for nuanced subtypes
- Seasoned biostatisticians that provide expertise in innovative, adaptive design using multiplicity in control, randomization approaches, graduation criteria and other cutting-edge data analysis to mitigate error rates and biases in complex breast cancer trials
- Advanced AI and tech-enabled strategies to model feasibility and identify, enroll and retain patient populations with specific subtypes or biomarkers or rare forms of breast cancer
- A patient-centric model that incorporates patient needs and perspectives throughout the clinical trial to ease the burden of participation and improve engagement, adherence and outcomes
- An Oncology Center of Excellence that integrates commercial, medical, patient, payer and regulatory insights into early clinical trial design to ensure every protocol is aligned with real-world value
Let’s talk about your next breast cancer clinical trial.
Breast cancer clinical trials face unique challenges due to the disease’s biological complexity, heterogeneity, diverse patient population and rapidly evolving treatment landscape. The biological heterogeneity of breast cancer creates opportunities to tailor interventions across the treatment continuum, but also introduces complexity in clinical trial design, requiring nuanced eligibility criteria and stratified enrollment strategies that can slow recruitment and complicate statistical analysis.
Trials must account for multiple molecular subtypes, which can limit eligible participants and complicate study design. Recruitment is often hindered by restrictive eligibility criteria, lack of awareness and underrepresentation. Additionally, the fast pace of therapeutic innovation can render control arms outdated, requiring adaptive trial designs that are resource-intensive and statistically demanding.
Innovative trial designs in breast cancer research are reshaping how treatments are tested and personalized.
- Adaptive trials, like I-SPY 2, allow modifications during the study based on early results, improving efficiency and responsiveness.
- Basket and umbrella trials focus on genetic mutations or molecular subtypes, enabling targeted therapies across or within cancer types.
- Platform trials combine these approaches under a single protocol, streamlining the evaluation of multiple treatments.
Additionally, pragmatic trials and real-world evidence studies assess therapies in everyday clinical settings, enhancing relevance. These designs accelerate drug development and support precision medicine in breast cancer by tailoring interventions to individual tumor biology.
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