INTRODUCTION Breast cancer is a major health issue among women due to its significant rates of mortality and morbidity. According to GLOBOCAN 2022, it is one of the most frequently diagnosed cancers globally. In India, breast cancer is the leading cancer affecting women, accounting for nearly 27% of all female cancers.1 While India ranks third worldwide in terms of incidence (192,020 cases), it has the highest mortality, with 98,337 deaths recorded in 2022. Globally, there are approximately 2.3 million new breast cancer cases, representing 11.7% of all cancers.2 By 2025, an estimated 1.4 million new cases are expected, with an age-standardized incidence rate of roughly 25/100,000 women.3 Alarmingly, around 60% of breast cancer cases in India are diagnosed at advanced stages (Stage III or IV). Breast cancer also contributes to the highest number of cancer-related deaths among women in India, with an estimated 98,337 fatalities annually. Clinical trials are essential for advancing Breast cancer prevention, early detection, treatment, and care. The Clinical Trials Registry of India (CTRI), established in 2007, provides a comprehensive database of clinical trials conducted across India, with mandatory registration since June 2009. This study analyses the trends in breast cancer clinical trials registered in CTRI between 2020 and 2025, providing insights into the evolving landscape of Breast cancer research in India. METHODS Data were extracted from the CTRI database using keywords. A total of 228 Breast cancer clinical trials registered between January 2020 and 2025 were included in this analysis. Information was categorized and analyzed based on year of registration, type of trial, nature of intervention, trial phase, sponsorship patterns, demographic characteristics, and type of disease were analyzed using SPSS version 21 (IBM Corp., Armonk, NY, USA). RESULTS The percentage distribution of breast cancer clinical trials registered between 2020 and 2025 demonstrated notable temporal variations. A modest decline was observed from 2020 (16.2%) to 2021 (13.5%), followed by an upward trajectory beginning in 2022 (20.1%) and peaking at 25.7% in 2025, reflecting an increase in research activity. The majority (67%) enrolled female participants exclusively, while 33% included both genders. Most studies were interventional (51.7%), followed by observational (30%), and BA/BE studies (17.5%). Among interventional trials, Phase 3 (36%) and Phase 4 (35%) predominated. Academic institutions (41%) were the main sponsors, followed by government (37%) and industry (22%). Maharashtra (18%) and Delhi (12.5%) led regionally. Drug-based (39%) interventions were the most common, followed by surgical (22%), radiation (17.5%), behavioral (11.4%), and supportive (9.6%). The Study addressed benign (43%), malignant (17%), and both (40%) conditions. DISCUSSION The analysis of breast cancer clinical trials registered in the CTRI demonstrates a steadily expanding oncology research landscape in India, with a predominance of Phase III randomized controlled trials. This reflects a strong national commitment to evidence-based oncology practice and aligns with the global emphasis on validating established therapies. However, the scarcity of early-phase (Phase I and II) studies indicates a gap in indigenous drug discovery and translational research capacity.4 The concentration of trial sites in urban tertiary-care academic centers underscores India’s strong metropolitan research infrastructure but raises concerns regarding equitable access and for patients from rural areas, potentially limiting generalizability. Expanding networks to include Tier II and rural oncology units could enhance representativeness and inclusivity.5 Pharmacologic investigations, particularly in targeted therapy and immunotherapy, mirror international research priorities and highlight India’s growing integration into the global oncology ecosystem. Yet, the urban-centric nature of research may restrict timely access to advanced treatment in resource-limited settings. Strategic partnerships between academic institutions, government programs, and regional cancer centers could decentralize trials and improve access. Integrating community-level initiatives, such as mobile mammography units, tele-oncology consultations, and artificial intelligence-assisted mammogram interpretation, enhances early detection and screening, especially in underserved regions. These innovations, combined with equitable research expansion, hold promise to strengthen population-level outcomes in India’s fight against breast cancer. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Lakshmi et al. (Sat,) studied this question.