Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ - Full Text View

Sponsors and Collaborators:	UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00290745

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: letrozole Drug: tamoxifen citrate Procedure: conventional surgery Procedure: neoadjuvant therapy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Citric acid Sodium Citrate Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Primary Hormonal Therapy for Ductal Carcinoma in Situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Tumor volume change as measured by MRI [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in tumor biomarkers and the longest diameter of the tumor as measured by mammography and MRI [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290745

Locations

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222

Sponsors and Collaborators

UCSF Helen Diller Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	E. Shelley Hwang, MD	UCSF Helen Diller Family Comprehensive Cancer Center
Principal Investigator:	Laura J. Esserman, MD, MBA	UCSF Helen Diller Family Comprehensive Cancer Center
Principal Investigator:	Cheryl A. Ewing, MD, FACS	UCSF Helen Diller Family Comprehensive Cancer Center
Principal Investigator:	Frederic M. Waldman, MD, PhD	UCSF Helen Diller Family Comprehensive Cancer Center
Principal Investigator:	Nola M. Hylton, PhD	UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Study ID Numbers:	CDR0000465205, UCSF-017513, UCSF-H10367-19435-05
Study First Received:	February 9, 2006
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00290745
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer in situ
ductal breast carcinoma in situ

Study placed in the following topic categories:

Skin Diseases
Citric Acid
Breast Neoplasms
Letrozole
Tamoxifen
Carcinoma
Carcinoma, Ductal

Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Estrogen Antagonists
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Ductal, Lobular, and Medullary
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009