Overcoming Barriers to Clinical Trials Cooperation: The Breast International Group Example

Clinical trials cooperation is not a luxury; it is a necessity, now more than ever, first in light of the segmentation of tumors according to their molecular targets—which are being matched to an increasing number of competitive drugs—and second because it is the only chance to maintain academic research centered on addressing patients’ needs. In its 21 years of existence, the Breast International Group, an umbrella organization supporting the activities of 54 member groups across six continents, has been confronted with challenges that include (1) keeping trust and motivation within the network; (2) improving the interface between academia and industry; (3) improving patient involvement and trust in clinical trials; and (4) fundraising for noncommercial research. We describe how these challenges have been addressed so far, with the hope of empowering the next generation of clinical investigators.

Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors

An important challenge in the field of cancer is finding the balance between delivering effective treatments and avoiding adverse effects and financial toxicity caused by innovative, yet expensive, drugs. To address this, several treatment de-escalation trials have been conducted, but only a few of these have provided clear answers. A few trials had poor accrual or had design flaws that led to conflicting results. Members of the Breast International Group (BIG) and North American Breast Cancer Group (NABCG) believe the way forward is to understand the lessons from these trials and listen more carefully to what truly matters to our patients. We reviewed several adjuvant trials of different cancer types and developed a road map for improving the design and implementation of future de-escalation trials. The road map incorporates patients’ insights obtained through focused group discussions across the BIG-NABCG networks. Considerations for the development of de-escalation trials for systemic adjuvant treatment, including noninferiority trial design, choice of end points, and prioritization of a patient’s perspectives, are presented in this consensus article.

A Global Perspective on Cooperation

Breast cancer research is resource intensive, and therefore many international and national breast cancer networks have been created. Some of these are mentioned in this chapter, the most important being the Breast International Group and North American Breast Cancer Groups. The success of these networks depends on many factors, among which a good model of clinical research collaboration is essential, as is being able to cope with recent developments in molecular biology. Publicly and privately supported clinical studies around the world can be explored via ClinicalTrials.gov. There, the evolution of breast cancer research in 205 countries can be observed, including the emergence of Asia in this field. Looking forward, better international regulation of trials is needed.