Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00290745
First received: February 9, 2006
Last updated: March 28, 2014
Last verified: March 2014
  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 ]

Enrollment: 56
Study Start Date: January 2004
Study Completion Date: June 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 28, 2014
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 July 24, 2014