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Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005886
First Posted: August 29, 2003
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Kansas Medical Center
  Purpose

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.

PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast cancer.


Condition Intervention Phase
Breast Cancer Drug: arzoxifene hydrochloride Drug: tamoxifen citrate Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Study Start Date: July 2000
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

  • Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily.

Upon completion of phase I, all treatment centers begin phase II of the study.

  • Phase II: Patients are randomized to receive either oral tamoxifen or oral placebo daily.

Treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy) in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 and 2 weeks after surgery.

PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for this study within 18 months.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed noninvasive or small invasive breast cancer

    • Low or intermediate grade (ductal carcinoma in situ, T1, or T2) OR
    • Estrogen and/or progesterone receptor positive
    • Largest mass no greater than 5 cm
    • Clustered microcalcifications as only abnormality allowed with no upper size limit
    • If no distinction between mass and microcalcifications, size as 1 lesion
  • Lumpectomy or mastectomy must be planned for 2-6 weeks from start of study
  • No evidence of metastases from any malignancy
  • Hormone receptor status:

    • Estrogen and progesterone receptor positive (unless low or intermediate grade tumor)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Postmenopausal by one of the following:

    • Prior oophorectomy
    • Over age 50 with prior hysterectomy, ovaries remaining
    • Uterus and ovaries intact and no menstrual period for more than 3 months

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL
  • Absolute granulocyte count greater than 1,000/mm^3

Hepatic:

  • Albumin greater than 3 g/dL
  • Bilirubin less than 1.5 mg/dL
  • AST less than 100 U/L
  • Alkaline phosphatase less than 200 U/L

Renal:

  • Creatinine less than 1.5 mg/dL

Cardiovascular:

  • No history of deep vein thrombosis

Pulmonary:

  • No prior pulmonary embolus

Other:

  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 1 year since prior chemotherapy

Endocrine therapy:

  • At least 1 year since prior aromatase inhibitors, antiestrogens, or LH agonists/antagonists
  • No concurrent hormone replacement therapy or oral contraceptives (from time of randomization)

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent treatment for other malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005886


Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States, 92262
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
United States, Texas
U.S. Oncology Research Inc.
Dallas, Texas, United States, 75246
Sponsors and Collaborators
University of Kansas Medical Center
National Cancer Institute (NCI)
Investigators
Study Chair: Carol J. Fabian, MD University of Kansas
  More Information

Publications:
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00005886     History of Changes
Other Study ID Numbers: CDR0000067956
KUMC-7813-99
KUMC-HSC-7419-98
NCI-P00-0158
First Submitted: June 2, 2000
First Posted: August 29, 2003
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by University of Kansas Medical Center:
stage I breast cancer
stage II breast cancer
ductal breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents