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Updated: Jul 20, 2026
Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Breast cancer chemoprevention: current challenges and a look toward the future
Carol J Fabian1, Bruce F Kimler
1Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS 66160, USA. cfabian@kumc.edu
Abstract:
There is a need to develop new prevention agents for breast cancer risk reduction that would have fewer side effects than the approved agent, tamoxifen, and/or would be effective in preventing estrogen receptor-negative or tamoxifen-resistant, estrogen receptor-positive breast cancers. There also is a need to improve the accuracy of present risk assessment models and to incorporate tissue-based biomarkers to supplement risk prediction tools. Candidate risk biomarkers include the serum hormones insulin-like growth factor-1 and its binding protein-3, mammographic breast density, nipple aspirate fluid production, and breast tissue evidence of proliferative breast disease (intraepithelial neoplasia). A variety of techniques have been developed to randomly sample breast tissue to detect precancerous changes and/or detect modulation of proliferation in response to a prevention agent. Based on molecular abnormalities observed in breast intraepithelial neoplasia, a number of drug classes and combinations are suggested as potential chemoprevention approaches. Clinical trial models have been developed to select the appropriate drug dose for subsequent biomarker modulation chemoprevention trials in which the use of surrogate endpoint biomarkers as indicators of efficacy is being explored. If these biomarkers can be validated and shown to reliably predict and monitor response in phase I/II prevention trials, and if favorable modulation is correlated with subsequent decreased cancer incidence, biomarkers may replace cancer incidence as the endpoint in future phase III trials, dramatically reducing the time and expense associated with new prevention drug development.
Insights
Developing novel breast cancer prevention agents and improving risk assessment are crucial. Biomarkers show promise for predicting efficacy and potentially replacing cancer incidence in trials, reducing drug development time.
Area of Science:
- Oncology
- Preventive Medicine
- Biomarker Research
Background:
- Current breast cancer risk reduction strategies, like tamoxifen, have limitations, including side effects and limited efficacy against certain breast cancer subtypes (estrogen receptor-negative or tamoxifen-resistant, estrogen receptor-positive).
- Existing risk assessment models require enhancement, particularly through the integration of tissue-based biomarkers to improve prediction accuracy.
- There is a critical need for novel chemoprevention agents with improved side effect profiles and broader efficacy.
Purpose of the Study:
- To explore the development of new breast cancer prevention agents with fewer side effects and broader efficacy.
- To investigate the integration of tissue-based biomarkers into risk assessment models for improved prediction.
- To evaluate the potential of biomarkers as surrogate endpoints in clinical trials for breast cancer prevention.
Main Methods:
- Identification of candidate risk biomarkers, including serum hormones (insulin-like growth factor-1, binding protein-3), mammographic breast density, nipple aspirate fluid, and breast tissue proliferative disease (intraepithelial neoplasia).
- Development of techniques for random breast tissue sampling to detect precancerous changes and assess proliferation modulation.
- Establishment of clinical trial models for dose selection and biomarker modulation chemoprevention trials.
Main Results:
- Molecular abnormalities in breast intraepithelial neoplasia suggest potential chemoprevention drug classes and combinations.
- Biomarker modulation chemoprevention trials are exploring the use of surrogate endpoints to indicate efficacy.
- Validation of biomarkers could lead to their use in predicting and monitoring response to prevention agents.
Conclusions:
- Validated biomarkers could significantly enhance breast cancer risk prediction and monitoring.
- The use of biomarkers as surrogate endpoints in phase III trials could dramatically reduce the time and cost of developing new breast cancer prevention drugs.
- Further research into novel chemoprevention agents and biomarker validation is essential for advancing breast cancer prevention efforts.
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