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

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. Identifier: NCT00005886
Recruitment Status : Completed
First Posted : August 29, 2003
Last Update Posted : January 13, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Kansas Medical Center

June 2, 2000
August 29, 2003
January 13, 2017
July 2000
August 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005886 on Archive Site
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Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer

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.


  • 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.

Phase 1
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Breast Cancer
  • Drug: arzoxifene hydrochloride
  • Drug: tamoxifen citrate
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Fabian CJ, Kimler BF, Anderson J, Tawfik OW, Mayo MS, Burak WE Jr, O'Shaughnessy JA, Albain KS, Hyams DM, Budd GT, Ganz PA, Sauter ER, Beenken SW, Grizzle WE, Fruehauf JP, Arneson DW, Bacus JW, Lagios MD, Johnson KA, Browne D. Breast cancer chemoprevention phase I evaluation of biomarker modulation by arzoxifene, a third generation selective estrogen receptor modulator. Clin Cancer Res. 2004 Aug 15;10(16):5403-17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2002
August 2002   (Final data collection date for primary outcome measure)


  • 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)



  • 18 and over


  • 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


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


  • 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


  • Creatinine less than 1.5 mg/dL


  • No history of deep vein thrombosis


  • No prior pulmonary embolus


  • Not pregnant or nursing


Biologic therapy:

  • Not specified


  • 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)


  • Not specified


  • See Disease Characteristics


  • No concurrent treatment for other malignancy
Sexes Eligible for Study: Female
18 Years to 120 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Kansas Medical Center
University of Kansas Medical Center
National Cancer Institute (NCI)
Study Chair: Carol J. Fabian, MD University of Kansas
University of Kansas Medical Center
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP