Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00290745
First received: February 9, 2006
Last updated: September 25, 2012
Last verified: September 2012
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Primary Hormonal Therapy for Ductal Carcinoma in Situ: Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Tumor volume change as measured by MRI [ Time Frame: 3 months following baseline screening ] [ 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 [ Time Frame: 3 months following baseline screening ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | January 2004 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: tamoxifen or letrozole
tamoxifen or letrozole work in treating women with ductal carcinoma in situ
|
Drug: letrozole Drug: tamoxifen citrate Procedure: conventional surgery Procedure: neoadjuvant therapy |
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 | |
| San Francisco, California, United States, 94115 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | E. Shelley Hwang, MD, MPH | University of California, San Francisco |
| Principal Investigator: | Laura J. Esserman, MD, MBA | University of California, San Francisco |
| Principal Investigator: | Cheryl A. Ewing, MD, FACS | University of California, San Francisco |
| Principal Investigator: | Frederic M. Waldman, MD, PhD | University of California, San Francisco |
| Principal Investigator: | Nola M. Hylton, PhD | University of California, San Francisco |
More Information
Additional Information:
Publications:
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.
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00290745 History of Changes |
| Other Study ID Numbers: | CDR0000465205, UCSF-017513, UCSF-H10367-19435-05 |
| Study First Received: | February 9, 2006 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
breast cancer in situ ductal breast carcinoma in situ |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Tamoxifen |
Letrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013