The field of breast cancer research has seen significant advancements in recent years, particularly in the realm of clinical trials aimed at improving disease management. Traditional clinical trials often require large participant numbers and extended durations to evaluate the efficacy of experimental drugs, posing challenges in terms of time and resource allocation. The ISPY2 clinical trial represents a paradigm shift by employing an adaptive platform that minimizes these constraints. This trial utilizes a master protocol, allowing for the simultaneous investigation of multiple treatment regimens and the seamless integration of new drugs without halting the study. Recent studies have highlighted the importance of predictive biomarkers, which are associated with breast cancer subtypes, in enhancing the precision of targeted therapies. Despite the progress, standard biomarkers used over the past decade have not significantly optimized treatment outcomes, underscoring the need for innovative approaches. The ISPY2 trial addresses this gap by leveraging collaboration between scientists and statisticians to refine biomarker classifications, ultimately aiming to improve patient outcomes through more effective and less toxic treatments.
This research topic aims to explore the potential of adaptive clinical trial platforms, like ISPY2, in revolutionizing breast cancer treatment. The primary objective is to investigate how predictive biomarkers can be utilized to tailor therapies that maximize patient response while minimizing toxicity. Key questions include the efficacy of this adaptive model in accelerating drug development and its impact on treatment pathways compared to traditional methods.
To gather further insights in the adaptive clinical trial landscape for breast cancer, we welcome articles addressing, but not limited to, the following themes:
- The role of predictive biomarkers in personalizing breast cancer treatment.
- Comparative analysis of adaptive versus traditional clinical trial methodologies.
- Case studies demonstrating successful implementation of adaptive trial designs.
- Collaborative efforts between academia and industry in advancing clinical trial innovations.
- Challenges and solutions in regulatory policies for adaptive trial frameworks.
- Long-term patient outcomes and quality of life improvements through targeted therapies.
- Ethical considerations in adaptive clinical trial designs.
Please note: Manuscripts consisting solely of bioinformatics, computational analysis, or predictions of public databases which are not accompanied by validation (independent clinical or patient cohort, or biological validation in vitro or in vivo, which are not based on public databases) are not suitable for publication in this journal.
Keywords:
Clinical trial, breast cancer, ISPY 2, toxicity, adaptive clinical trial
Important Note:
All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
The field of breast cancer research has seen significant advancements in recent years, particularly in the realm of clinical trials aimed at improving disease management. Traditional clinical trials often require large participant numbers and extended durations to evaluate the efficacy of experimental drugs, posing challenges in terms of time and resource allocation. The ISPY2 clinical trial represents a paradigm shift by employing an adaptive platform that minimizes these constraints. This trial utilizes a master protocol, allowing for the simultaneous investigation of multiple treatment regimens and the seamless integration of new drugs without halting the study. Recent studies have highlighted the importance of predictive biomarkers, which are associated with breast cancer subtypes, in enhancing the precision of targeted therapies. Despite the progress, standard biomarkers used over the past decade have not significantly optimized treatment outcomes, underscoring the need for innovative approaches. The ISPY2 trial addresses this gap by leveraging collaboration between scientists and statisticians to refine biomarker classifications, ultimately aiming to improve patient outcomes through more effective and less toxic treatments.
This research topic aims to explore the potential of adaptive clinical trial platforms, like ISPY2, in revolutionizing breast cancer treatment. The primary objective is to investigate how predictive biomarkers can be utilized to tailor therapies that maximize patient response while minimizing toxicity. Key questions include the efficacy of this adaptive model in accelerating drug development and its impact on treatment pathways compared to traditional methods.
To gather further insights in the adaptive clinical trial landscape for breast cancer, we welcome articles addressing, but not limited to, the following themes:
- The role of predictive biomarkers in personalizing breast cancer treatment.
- Comparative analysis of adaptive versus traditional clinical trial methodologies.
- Case studies demonstrating successful implementation of adaptive trial designs.
- Collaborative efforts between academia and industry in advancing clinical trial innovations.
- Challenges and solutions in regulatory policies for adaptive trial frameworks.
- Long-term patient outcomes and quality of life improvements through targeted therapies.
- Ethical considerations in adaptive clinical trial designs.
Please note: Manuscripts consisting solely of bioinformatics, computational analysis, or predictions of public databases which are not accompanied by validation (independent clinical or patient cohort, or biological validation in vitro or in vivo, which are not based on public databases) are not suitable for publication in this journal.
Keywords:
Clinical trial, breast cancer, ISPY 2, toxicity, adaptive clinical trial
Important Note:
All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.