Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.
PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ.
Drug: tamoxifen citrate
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Primary Hormonal Therapy for Ductal Carcinoma in Situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer|
- Tumor volume change as measured by MRI [ Time Frame: 3 months following baseline screening ] [ Designated as safety issue: No ]
- Changes in tumor biomarkers and the longest diameter of the tumor as measured by mammography and MRI [ Time Frame: 3 months following baseline screening ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||June 2011|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Active Comparator: tamoxifen or letrozole
tamoxifen or letrozole work in treating women with ductal carcinoma in situ
|Drug: letrozole Drug: tamoxifen citrate Procedure: conventional surgery Procedure: neoadjuvant therapy|
- 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 following treatment.
- Identify those cellular antigens which are altered by hormonal therapy.
- Determine which cellular antigens are predictive of clinical response to hormonal therapy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290745
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||E. Shelley Hwang, MD, MPH||University of California, San Francisco|
|Principal Investigator:||Laura J. Esserman, MD, MBA||University of California, San Francisco|
|Principal Investigator:||Cheryl A. Ewing, MD, FACS||University of California, San Francisco|
|Principal Investigator:||Frederic M. Waldman, MD, PhD||University of California, San Francisco|
|Principal Investigator:||Nola M. Hylton, PhD||University of California, San Francisco|