Research issues affecting preoperative systemic therapy for operable breast cancer.
Antonio C Wolff1, Donald Berry, Lisa A Carey
1The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Room 189, Baltimore, MD 21231-1000, USA. awolff@jhmi.edu
Summary
Preoperative systemic therapy (PST) for operable breast cancer enhances breast conservation and serves as a vital research platform. It enables in vivo treatment effect assessment, potentially leading to smaller, more efficient clinical trials for specific breast cancer subtypes.
Area of Science:
- Oncology
- Clinical Trials
- Translational Research
Background:
- Preoperative systemic therapy (PST) in operable breast cancer offers modest gains in breast conservation rates.
- PST presents a unique research platform for evaluating treatment efficacy directly in patients.
Purpose of the Study:
- To review critical research design issues for PST trials in operable breast cancer.
- To explore the potential of PST as a platform for refining future adjuvant trial designs.
Main Methods:
- Review of critical research issues including trial endpoints, markers, and statistical designs.
- Discussion of optimal tumor subtype selection and novel trial designs like non-therapeutic windows.
- Consideration of ethical and advocacy aspects.
Main Results:
- PST allows in vivo assessment of treatment effects, aiding in the design of smaller, targeted trials.
- Early outcome observations in subgroups can inform larger definitive adjuvant trials.
- Potential for mid-course therapeutic adjustments requires validated intermediate endpoints.
Conclusions:
- PST is a valuable research tool for operable breast cancer, improving trial efficiency and design.
- Successful implementation of PST research requires a multidisciplinary team.
- Further research into endpoints, markers, and trial designs is crucial for optimizing PST's potential.
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