How Are Clinical Trials for Breast Cancer Treatments Currently Being Designed? A Clinical Trial Database Analysis
Author(s)
Charlotte Verbeke, MSc1, Justine De Tavernier, BSc1, Annette Eeraerts, BSc1, Lara Torfs, BSc1, Patrick Neven, PhD2, Isabelle Huys, PharmD, PhD1.
1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium, 2Department of Obstetrics and Gynaecology, Division of Gynaecological Oncology, UZ Leuven, Leuven, Belgium.
1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium, 2Department of Obstetrics and Gynaecology, Division of Gynaecological Oncology, UZ Leuven, Leuven, Belgium.
OBJECTIVES: Breast cancer is highly prevalent among women, with a severe impact on patients’ quality of life and overall survival. New treatments are being developed and tested in clinical trials. However, questions do arise whether current clinical trials meet all needs, including both clinical needs and patients' perceived needs. The aim of this database analysis was to provide a comprehensive overview of breast cancer clinical trials, focusing on I) the design, II) outcomes, and III) patient involvement.
METHODS: The ClinicalTrials.gov database was searched for breast cancer trials. The search was conducted in November 2024. The following inclusion filters were chosen: i) female, ii) adult participants (18-64 years old), iii) completed trials, iv) trials with results; v) phase III and IV, vi) interventional studies. The eligible trials were systematically screened. The data was compiled in a predefined excel table and analyzed descriptively.
RESULTS: 280 trials were identified and analyzed. Most of the trials (n=244, 87%) were phase III, investigated treatments (n=216, 77%) and involved chemotherapy (n=113, 40%) and targeted therapy (n= 117, 42%) as therapy options. In 151 (54%) trials, the breast cancer subtype included was not specified. The four primary outcomes most identified were i) progression free survival (n=64, 23%), ii) disease free survival (n=41, 15%), iii) overall survival (n=23, 8%) and iv) pathologic complete response (n=16, 6%). In 103 (37%) trials, patients’ needs were assessed via breast cancer-specific and/or non-breast cancer-specific questionnaires.
CONCLUSIONS: Preliminary findings show that in many trials it remains unclear i) which subtypes of breast cancer patients are included, ii) whether patients are involved in the trial design, and iii) how their needs are evaluated.
METHODS: The ClinicalTrials.gov database was searched for breast cancer trials. The search was conducted in November 2024. The following inclusion filters were chosen: i) female, ii) adult participants (18-64 years old), iii) completed trials, iv) trials with results; v) phase III and IV, vi) interventional studies. The eligible trials were systematically screened. The data was compiled in a predefined excel table and analyzed descriptively.
RESULTS: 280 trials were identified and analyzed. Most of the trials (n=244, 87%) were phase III, investigated treatments (n=216, 77%) and involved chemotherapy (n=113, 40%) and targeted therapy (n= 117, 42%) as therapy options. In 151 (54%) trials, the breast cancer subtype included was not specified. The four primary outcomes most identified were i) progression free survival (n=64, 23%), ii) disease free survival (n=41, 15%), iii) overall survival (n=23, 8%) and iv) pathologic complete response (n=16, 6%). In 103 (37%) trials, patients’ needs were assessed via breast cancer-specific and/or non-breast cancer-specific questionnaires.
CONCLUSIONS: Preliminary findings show that in many trials it remains unclear i) which subtypes of breast cancer patients are included, ii) whether patients are involved in the trial design, and iii) how their needs are evaluated.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR122
Topic
Clinical Outcomes, Patient-Centered Research
Topic Subcategory
Patient Engagement, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology