Advance your research in a competitive, global landscape with a leading breast cancer CRO
As the most commonly diagnosed cancer in women, breast cancer has a devastating effect on women’s health. Parexel is committed to fighting it. Our end-to-end capabilities allow us to support you across every area of clinical trials — covering all phases of development and various study types, including:
- Diagnostic studies for improved accuracy and efficiency
- Treatment studies, which include chemotherapy, targeted therapies, immunotherapies, hormone therapies, and combination therapies
- Early (adjuvant and neoadjuvant) and metastatic breast cancer studies
- Studies focused on specific breast cancer subtypes, including HER2-positive, TNBC, and others
- Molecular-guided precision studies
With our experience comes a clear understanding of the challenges breast cancer studies face: patient recruitment and retention, complex trials, the need to rapidly adapt as treatments evolve, and more. All are challenges we know well and are equipped to overcome, so your treatment can get to the patients who need it sooner.
Experience in the past 5 years in breast cancer
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breast cancer projects
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unique sites
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patients
Advanced patient recruitment
Breast cancer studies often require large patient populations with specific subtypes or biomarkers, each requiring targeted study designs and distinct endpoints. As a proven breast cancer CRO, we leverage real-world data, AI-driven feasibility models, and strong relationships with sites and advocacy groups to reach and retain highly specific patient cohorts around the world — even in competitive environments.
Patient-first model
We take a “whole patient” approach, considering the patient’s needs at every stage of the journey to improve engagement, adherence, and trial outcomes. This includes implementing decentralized trials, ePRO tools, flexible site strategies, and more. We also engage in extensive education. The more sites and patients know about the study and drug, along with its benefits, the more likely we are to succeed.
Expertise in an evolving treatment landscape
Rapid advancements in breast cancer treatment can make it difficult to design relevant studies. But our experience with complex trial design — including biomarker-driven studies, precision medicine, adaptive trial design, and decentralized trials — enable us to not only keep up, but get ahead of these changes.
Global regulatory experience
As breast cancer treatments evolve, our deep regulatory knowledge makes it possible to navigate approvals across different regions. We employ ex-agency regulators globally, and our experts have led successful submissions for breast cancer therapies across FDA, EMA, and other global agencies. We’ve also navigated expedited pathways like Fast Track and Breakthrough Therapy Designation.
Comprehensive services and seamless scalability
We offer end-to-end oncology CRO services, from early phase development through post-marketing studies, for continuity throughout the drug development process. As small biotech companies grow and their trials expand, our flexible model also allows us to scale up to support their changing needs.
Case study — Finishing patient recruitment six months early across 20 countries
A challenge we faced as a breast cancer CRO was a Phase III global study that involved 4,000 patients, 200 sites, and 20 countries over 4 continents. In enrollment, we faced strong competition for breast cancer patients, as well as complex inclusion/exclusion criteria and the need for cultural sensitivity in several regions. The need to import and export comparator drugs complicated logistics. By assigning an experienced team that understood medical practices, cultural norms, and regulatory variations in each country, we delivered a full-service solution that met all milestones — including finishing patient recruitment six months ahead of schedule.