Primary Hormonal Therapy for Ductal Carcinoma in Situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer
- Determine the clinical response in women with estrogen receptor-positive ductal
carcinoma in situ (DCIS) treated with neoadjuvant hormonal therapy comprising tamoxifen
or letrozole, by evaluating the maximal change in tumor diameter on mammography and MRI
- Identify those cellular antigens which are altered by hormonal therapy.
- Determine which cellular antigens are predictive of clinical response to hormonal
- Evaluate whether genomic changes or gene expression in DCIS are altered by hormonal
therapy and find candidate genes which are correlated with response to treatment.
OUTLINE: This is a pilot study.
Patients who are premenopausal receive oral tamoxifen once daily for 3 months in the absence
of unacceptable toxicity. Patients who are post menopausal receive oral letrozole once daily
for 3 months in the absence of unacceptable toxicity.
After 3 months of hormonal therapy, patients undergo lumpectomy or mastectomy.
After completion of study treatment, patients are followed every 6 months for 5 years and
then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor volume change as measured by MRI
3 months following baseline screening
E. Shelley Hwang, MD, MPH
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|