Breast (Edinburgh, Scotland) · 2026
Early termination of clinical trials enrolling patients with breast cancer: Reasons, determinants, and temporal patterns.
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Iannantuono Giovanni Maria, Daniele Gennaro, Mastrantoni Luca, Giannarelli Diana, Trapani Dario, Gyawali Bishal, Sganga Stefano, Giudice Elena, Riondino Silvia, Krasniqi Eriseld, Capici Serena, Pepe Francesca Fulvia, Torrisi Rosalba, Spinazzola Andrea, Bassolino Antonio, Meacci Arianna, Yazdanpanahardakani Khashayar, Padula Letizia, Rosenfeld Roberto, Carbognin Luisa, Lorusso Domenica, Curigliano Giuseppe, Gulley James L, Fabi Alessandra, Bria Emilio, Roselli Mario, Floudas Charalampos S, Cazzaniga Marina Elena
Аннотация
BACKGROUND: The occurrence of clinical trial termination before planned completion (or "early termination" [ET]) remains poorly characterized in the breast cancer field. This study investigates the reasons, determinants, and temporal patterns of ET in breast cancer trials.
METHODS: We conducted a cross-sectional study using the Aggregate Analysis of ClinicalTrials.gov (AACT) database, including breast cancer trials initiated between 2001 and 2025. Reasons for ET were identified and classified into predefined categories. Factors associated with ET were evaluated using multivariable logistic regression, and temporal patterns were assessed using competing risk analysis and a multivariable Fine-Gray subdistribution hazard model.
RESULTS: A total of 5251 trials were included. "Poor accrual" was the most common reason for ET (39.2%), followed by "sponsor decision or strategic reasons" (22.4%) and "operational or management issues" (13.4%). "Poor accrual" was the leading cause of ET among phase 2 and 3 trials, academic-sponsored studies, and single-center trials, whereas "sponsor decision or strategic reasons" predominated among phase 1 trials, industry-sponsored studies, and trials conducted globally. In multivariable logistic regression analyses, phase 2 trials had a higher likelihood of ET (OR = 1.48; P < .001), whereas multicenter studies (OR = 0.70; P < .001) and trials with non-treatment purposes (OR = 0.61; P < .001) had a lower likelihood of ET. Similar patterns were observed in the Fine-Gray model.
CONCLUSIONS: Early termination of breast cancer trials is a heterogeneous phenomenon, with distinct patterns based on study characteristics. Tailored strategies to improve trial feasibility, participant recruitment, and operational planning may reduce the risk of ET.
METHODS: We conducted a cross-sectional study using the Aggregate Analysis of ClinicalTrials.gov (AACT) database, including breast cancer trials initiated between 2001 and 2025. Reasons for ET were identified and classified into predefined categories. Factors associated with ET were evaluated using multivariable logistic regression, and temporal patterns were assessed using competing risk analysis and a multivariable Fine-Gray subdistribution hazard model.
RESULTS: A total of 5251 trials were included. "Poor accrual" was the most common reason for ET (39.2%), followed by "sponsor decision or strategic reasons" (22.4%) and "operational or management issues" (13.4%). "Poor accrual" was the leading cause of ET among phase 2 and 3 trials, academic-sponsored studies, and single-center trials, whereas "sponsor decision or strategic reasons" predominated among phase 1 trials, industry-sponsored studies, and trials conducted globally. In multivariable logistic regression analyses, phase 2 trials had a higher likelihood of ET (OR = 1.48; P < .001), whereas multicenter studies (OR = 0.70; P < .001) and trials with non-treatment purposes (OR = 0.61; P < .001) had a lower likelihood of ET. Similar patterns were observed in the Fine-Gray model.
CONCLUSIONS: Early termination of breast cancer trials is a heterogeneous phenomenon, with distinct patterns based on study characteristics. Tailored strategies to improve trial feasibility, participant recruitment, and operational planning may reduce the risk of ET.