Primary Hormonal Therapy for Ductal Carcinoma in Situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer
N/A
N/A
Female
Breast Cancer
Trial Information
Primary Hormonal Therapy for Ductal Carcinoma in Situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of ductal carcinoma in situ (DCIS) on core biopsy
- No evidence of contralateral breast disease or palpable masses on breast examination
- No presence or suspicion of invasive cancer, including contralateral invasive cancer,
on core biopsy and MRI
- No documented ipsilateral axillary adenopathy
- Planning to undergo lumpectomy or mastectomy
- Estrogen receptor (ER)-positive tumor by immunohistochemistry
PATIENT CHARACTERISTICS:
- Female patient
- Premenopausal or postmenopausal
- Postmenopausal is defined by any of the following:
- No spontaneous menses for ≥ 1 year
- Bilateral oophorectomy
- Radiation castration and amenorrheic for ≥ 3 months
- Follicle-stimulating hormone (FSH) > 20 IU/L AND off all hormonal therapy
(e.g., hormone replacement therapy or birth control pills) for ≥ 1 month
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No co-morbidities contraindicating the use of tamoxifen, including any of the
following:
- Prior history of thrombotic events
- History of hypercoagulable state
- History of endometrial hyperplasia
- Abnormal vaginal bleeding
- No history of contrast dye-related allergies/reactions
- No history of metal-containing prostheses or implants
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor volume change as measured by MRI
Outcome Time Frame:
3 months following baseline screening
Safety Issue:
No
Principal Investigator
E. Shelley Hwang, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000465205
NCT ID:
NCT00290745
Start Date:
January 2004
Completion Date:
Related Keywords:
- Breast Cancer
- breast cancer in situ
- ductal breast carcinoma in situ
- Breast Neoplasms
- Carcinoma
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
- Carcinoma, Ductal, Breast
- Carcinoma, Ductal
Name | Location |
|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
