Status:
COMPLETED
Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Novartis
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 19 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2011
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00290745
Start Date
February 19 2002
End Date
June 30 2011
Last Update
December 4 2020
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143