Clinical Research Directory

Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients

This study aims to evaluate the efficacy and safety of branded palbociclib (Ibrance®) compared to available local generic formulations (Palbociclib-IPI) in Iraqi patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (HR+ HER2- BC). This research aims to provide evidence

Wide-Angle Tomosynthesis and AI in Diagnostic Mammography

Breast cancer remains the most commonly diagnosed cancer and a leading cause of cancer-related mortality among women globally. Timely and accurate detection is crucial for improving prognosis and survival outcomes. While digital mammography has long served as the gold standard for screening, it is limited by overlapping tissue structures, particularly in women with dense breasts, which can obscure malignancies or create false positives. To address these limitations, digital breast tomosynthesis (DBT), especially wide-angle DBT, has been developed to offer three-dimensional imaging and reduce tissue overlap. Siemens' MAMMOMAT B.brilliant system, which incorporates wide-angle DBT, enhances spatial resolution and improves lesion conspicuity. This technology may offer significant benefits in diagnostic populations, where accuracy and confidence in imaging interpretation are crucial. In parallel, artificial intelligence (AI) tools such as the Transpara system have been introduced to further improve mammographic interpretation. Previously the evaluation of Transpara in a sample of 310 Japanese women and found that while human readers outperformed AI in overall diagnostic performance, the system showed promising sensitivity levels, highlighting the potential of AI as a decision-support tool rather than a standalone reader. More robust evidence is provided by the Mammography Screening with Artificial Intelligence (MASAI) trial, which assessed AI-supported screen reading in a controlled study of over 80,000 women. The trial found that AI-supported reading led to a comparable cancer detection rate as standard double reading (6.1 vs. 5.1 per 1000 participants) but reduced reading workload by 44.3% without increasing false positives or recall rates. A related analysis by the same team emphasized the capability of AI to triage exams effectively and highlighted that AI-flagged "extra high risk" mammograms accounted for a substantial portion (over 55%) of all screen-detected cancers, with a high positive predictive value. Despite these encouraging findings, most studies have been limited to screening-based settings. There remains a lack of prospective evidence on the real-world diagnostic application of wide-angle DBT and AI in populations at higher risk, such as symptomatic patients or those recalled from screening. This represents a critical knowledge gap, especially given increasing concerns about radiologist workload and diagnostic delays. The purpose of this prospective observational study is to evaluate the integration and diagnostic value of wide-angle tomosynthesis and AI (Transpara) in a clinical diagnostic setting. Specifically, it aims to assess their influence on radiologist confidence, diagnostic accuracy and the need for supplementary imaging. By addressing these questions, the study seeks to inform future implementation strategies that balance accuracy, efficiency, and clinical utility.

Neratinib Combined With Fulvestrant and Eribulin in the Treatment ofHR+/HER2+ Advanced Breast Cancer

This study aims to explore the efficacy and safety of neratinib combined with fulvestrant and eribulin in the treatment of HR+/HER2+ advanced breast cancer after trastuzumab deruxtecan resistance. The treatment regimen of neratinib + fulvestrant + eribulin in this study is expected to provide a new and effective therapeutic strategy for patients with triple-positive breast cancer who develop resistance to trastuzumab deruxtecan, and offer novel therapeutic insights for advanced triple-positive breast cancer.

The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling

The purpose of the CCANED-CIPHER study is to develop and validate an AI-based blood test for early cancer detection and to monitor treatment effectiveness in cancer patients. This two-phase, multi-center observational study aims to identify specific transcriptomic biomarkers in platelets and immune cells that distinguish cancer patients from healthy individuals and correlate with treatment outcomes. By analysing blood samples using artificial intelligence, the study seeks to create a safe, non-invasive method to enhance cancer diagnosis and monitor treatment responses over time.

Thyroid Dysfunction Induced by Radiotherapy Treatment in Patients with Breast Cancer

Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and improve long-term survival in high-risk breast cancer patients . However, RT-induced toxicities to adjacent normal tissues can lead to serious morbidity in cancer survivors . The thyroid regulates the body's metabolism via producing thyroxine (T4) and triiodothyronine (T3) hormones. As the thyroid is sensitive to RT, radiation-induced thyroid disorders have been reported in cancer patients who received radiation in the cervical or SCV regions . In breast cancer patients, RT to the SCV area has been associated with a higher incidence of Hypothyriodism, particularly in younger patients This complication may be associated with radiation-induced thyroid volume reduction . Recent studies,have reported a significant decrease in thyroid volume (14-30 %) in patients with laryngeal or nasopharyngeal carcinoma (NPC), suggesting an association between HT and post-RT thyroid atrophy . Little is known about the changes of thyroid gland volume based on local thyroid gland radiation dose and its correlations with incidence of HT. Our study aim the changes in thyroid volume of breast cancer patients who received RT to the SCV nodal area, to evaluate RT-induced thyroid gland evolution based on local radiation dose. We then assessed the association between thyroid volume changes and the incidence of post-RT Hypothyrodism in breast cancer patients. the aim of the study to diagnose subclinical hypothyroidism and biochemical changes in thyroid function after radiotherapy for breast cancer

Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29)

Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence. However, the risk of relapse remains significant, estimated at around 20% according to studies. The SOFT study, which compares the type of hormone therapy used in premenopausal patients, estimates a relapse risk of 21.1% at 8 years (1), especially when there is initial lymph node involvement. In fact, in cases of lymph node involvement, the cumulative relapse rate at 10 years after stopping hormone therapy ranges between 19% and 36% (2), and the risk of death from breast cancer 20 years after stopping hormone therapy is estimated at 28% to 49% (2). CDK4/6 inhibitors first demonstrated their efficacy at the metastatic stage. Abemaciclib improved median survival to 46.7 months compared to a median of 37.3 months with hormone therapy alone (Monarch 2 (3) and Monarch 3 (4)). Palbociclib showed in PALOMA-2 (5) an improvement in progression-free survival (24.8 months versus 14.5 months) without an improvement in overall survival. Ribociclib, in turn, demonstrated in MONALEESA 2 (6) an improvement in PFS (25.3 months versus 16 months) and in overall survival (63.9 months versus 51.4 months). These treatments have become the standard first-line treatment for patients with RH+ HER2 non-amplified breast cancer. Given the results in advanced lines, CDK4/6 inhibitors have been the subject of studies in localized breast cancer, particularly in this high-risk population where the recurrence rate remains significant. The MONARCH-E study, published on September 20, 2020 (7), led to the approval of Abemaciclib by European authorities at the time of the initial publication (median follow-up of 15.4 months) and to reimbursement starting in May 2023 after a second interim analysis (8) in this at-risk population, with a 5.6% reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone. It is crucial to clearly define the at-risk population in order to offer them treatment intensification while maintaining a satisfactory quality of life. The group benefiting from Abemaciclib presented grade III toxicity in 43% of cases and grade IV toxicity in 2.5%. Real-world data are needed to better understand the management and toxicity of this treatment.