Background: Breast cancer is the most diagnosed malignancy worldwide and a leading cause of cancer-related mortality in women. Clinical trials underpin advances in prevention, diagnosis and treatment; however, the landscape of breast cancer trials in low- and middle-income countries (LMICs) remains insufficiently characterised. This study aimed to describe the scope, design, interventions and funding of breast cancer clinical trials conducted in LMICs between January 2010 and December 2020.
Methods: We searched the Cochrane Central Register of Controlled Trials on 15 November 2023 for trials using the keywords ‘breast cancer’, ‘breast adenocarcinoma’ and ‘breast tumour’. Trials were classified by World Bank income category. Extracted variables included study design, primary purpose, time perspective, observational model, trial phase, intervention type, sample size, status, reason for termination, funding source and centre type. Descriptive statistics summarised trial characteristics.
Results: A total of 333 breast cancer trials were identified; Two trials (0.6%) were conducted in low-income countries and 331 (99.4%) in lower-middle-income countries; no trials conducted exclusively in upper-middle-income countries were identified within the registry during the study period. Most trials were interventional (85.3%), prospective (95.8%) and treatment-focused (71.5%). Drug-based interventions predominated (64.9%). Funding was primarily from pharmaceutical or biotechnology companies (53.2%), followed by academic or institutional (university-based) sources (39.6%). Only 7.5% of trials addressed prevention, screening and supportive care. Multicentre trials accounted for 53.8%, single-centre 46.3%.
Conclusion: Breast cancer trials in LMICs are predominantly interventional, pharmaceutically-funded and concentrated in lower-middle-income settings. There remains a substantial paucity of trials from low-income countries and in non-treatment domains such as prevention, screening and supportive care.
