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SHORTened duration of TAMoxifen for risk reduction in breast intraepithelial neoplasms in post-menopausal women.
The primary objective of this trial is to evaluate the efficacy of a shortened, low-dose chemoprevention regimen (tamoxifen 10 mg every other day for 18 months) in reducing the risk of developing invasive breast cancer or ipsilateral/contralateral breast recurrence in patients diagnosed with breast intraepithelial neoplasia (DCIS, ADH, ALH, LCIS) or those with an elevated 5-year Gail model risk (> 1.66%). This objective aims to determine whether further shortening the duration of low-dose therapy can maintain the meaningful risk reduction observed in prior trials (such as TAM-01) while minimizing treatment burden and toxicities.
Protocol Number:
042606
Phase:
Phase II
Applicable Disease Sites:
Breast
Principal Investigator:
Mridula A George
Scope:
Local
Participating Institutions:
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
- Rutgers University
For further information about clinical trials, please contact us at 732-235-7356.