Giovanni Maria Iannantuono, Medical Oncologist at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, shared a post on LinkedIn:
“Are you a stakeholder involved in designing clinical trials for patients with breast cancer?
Clinical trials require major investments in people, time, and resources. When they end prematurely, valuable opportunities to generate evidence may be lost.
And sometimes, the best way to improve future trials is to learn from those that did not reach completion.
In our new study published in The Breast, we analyzed more than 5000 breast cancer clinical trials over 25 years, providing the first comprehensive overview of the reasons and determinants of early termination (ET).
So, what did we learn?
- Recruitment is still the biggest challenge. Poor accrual accounted for 39.2% of ET, followed by sponsor/strategic decisions (22.4%) and operational/management issues (13.4%).
- Different trials stop for different reasons. Poor accrual dominated in phase 2–3 trials, while sponsor/strategic decisions were more common in phase 1 trials.
- Trial design matters. Phase 2 trials had a higher likelihood of ET, whereas multicenter and non-treatment trials had a lower likelihood.
Understanding why different trials stop early may help us design tailored strategies to prevent avoidable early termination.
Grateful to all co-authors: Bishal Gyawali, Dario Trapani, Stefano Sganga, Elena Giudice, Eriseld Krasniqi, Andrea Spinazzola, Antonio Bassolino, Arianna Meacci, Khashayar Yazdanpanah, Domenica Lorusso, Giuseppe Curigliano, James Gulley, Alessandra Fabi, Emilio Bria
As this is my first project since joining Fondazione IRCCS San Gerardo dei Tintori, I would like to thank a few people who made it possible:
- Luca Mastrantoni, for always raising the bar and bringing every project to a higher level;
- Charalampos (Harris) Floudas, for his mentorship, constant support, and generosity, always finding a way to be present despite the time zones;
- Gennaro Daniele, for his mentorship, for helping me grow, and for giving me the tools to think, create, and develop projects like this — proving that distance is never a barrier;
- Marina Elena Cazzaniga, for welcoming me so warmly, allowing me to continue my journey in phase 1 clinical research, while guiding me through my first steps in the breast cancer field.”
You can also read: 10 Clinical Trials on Immunotherapy in Triple Negative Breast Cancer
