Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ

• Status: Completed
• Trial end date: 2011-06-30
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI); Novartis
• Treatments: Letrozole; Tamoxifen

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