Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ

Basic Trial Information

Objectives

1. 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.
2. Identify those cellular antigens which are altered by hormonal therapy.
3. Determine which cellular antigens are predictive of clinical response to hormonal therapy.
4. 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.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics

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

Expected Enrollment

A total of 40 patients will be accrued for this study.

Outcomes

Tumor volume change as measured by MRI

Changes in tumor biomarkers and the longest diameter of the tumor as measured by mammography and MRI

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.

Chen YY, DeVries S, Anderson J, et al.: Pathologic and biologic response to preoperative endocrine therapy in patients with ER-positive ductal carcinoma in situ. BMC Cancer 9: 285, 2009.[PUBMED Abstract]

Swain RS, Chen YY, Wa C, et al.: Pathologic and biologic response to neoadjuvant anti-estrogen (AE) therapy in patients with ductal carcinoma in situ (DCIS). [Abstract] United States and Canadian Academy of Pathology 95th Annual Meeting, February 11-17, 2006, Atlanta, GA. A-186, 2006.

Trial Contact Information

Trial Lead Organizations

UCSF Helen Diller Family Comprehensive Cancer Center

E. Shelley Hwang, MD, MPH, Principal investigator		Ph: 415-353-7908; 800-888-8664
Laura Esserman, MD, MBA, Principal investigator		Ph: 415-885-7691; 800-888-8664
Cheryl Ewing, MD, FACS, Principal investigator		Ph: 415-353-7908; 800-888-8664 Email: cheryl.ewing@ucsfmedctr.org
Frederic Waldman, MD, PhD, Principal investigator		Ph: 415-476-3821; 800-888-8664 Email: waldman@cc.ucsf.edu
Nola Hylton, PhD, Principal investigator		Ph: 415-476-8856; 800-888-8664

U.S.A.
California
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222

Registry Information
Official Title		Primary Hormonal Therapy for Ductal Carcinoma in situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer
Trial Start Date		2004-01-01
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00290745
Date Submitted to PDQ		2005-12-14
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA82103

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