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Issues in clinical research for metastatic breast cancer
Semih Dogan1, Fabrice Andre, Monica Arnedos
1aINSERM Unit U981, Université Paris Sud, Gustave Roussy bDepartment of Medical Oncology, Gustave Roussy, Villejuif, France.
Purpose Of Review:
Technical advances and progresses in tumor biology hold promise for the advent of new anticancer agents. These changes are impacting the conduct and design of clinical trials. This review describes the changing landscape of clinical research in metastatic breast cancer (MBC).
Recent Findings:
Clinical trials in breast cancer that started between 2007 and 2011 were analyzed. In the metastatic setting, 72% (n = 479) of these studies evaluated targeted therapies and 21% (n = 139) conventional treatments. During this period, the number of phase II trials decreased over time, whereas biology-driven studies, although small in terms of absolute number, now represent 15% of the total. Nevertheless, genomic segments are too rare to allow conventional drug development and require changes in the way clinical trials are being done. Several options are being explored to address this challenge: develop large consortium, perform molecular screening in larger populations, develop clinical trials testing algorithm for treatment decision, and no longer drugs.
Summary:
The landscape of clinical research in MBC is changing with the development of molecular medicine. Research institutions and cooperative groups will need to adapt to this changing landscape in clinical research.
Insights
Advances in tumor biology are transforming clinical trials for metastatic breast cancer (MBC). Research must adapt to molecular medicine for developing novel targeted therapies and improving patient outcomes.
Area of Science:
- Oncology
- Translational Research
- Clinical Trial Design
Background:
- Tumor biology advancements are driving the development of new anticancer agents.
- These scientific progresses necessitate changes in clinical trial conduct and design.
- The landscape of clinical research in metastatic breast cancer (MBC) is evolving.
Purpose of the Study:
- To review the changing landscape of clinical research in metastatic breast cancer (MBC).
- To analyze trends in clinical trial design and therapeutic approaches.
- To discuss the impact of molecular medicine on breast cancer research.
Main Methods:
- Analysis of breast cancer clinical trials initiated between 2007 and 2011.
- Categorization of trials based on therapeutic agents (targeted vs. conventional).
- Evaluation of trial phases and the emergence of biology-driven studies.
Main Results:
- Targeted therapies dominated metastatic breast cancer trials (72%), with conventional treatments in 21%.
- A decrease in Phase II trials was observed, while biology-driven studies increased to 15%.
- Genomic segments are often too rare for traditional drug development, prompting new trial strategies.
Conclusions:
- Molecular medicine is reshaping clinical research in metastatic breast cancer.
- Current trial models face challenges due to rare genomic targets.
- Research institutions and cooperative groups must adapt to new clinical research paradigms, including consortiums and molecular screening.
