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

Breast Cancer Clinical Trial

Official title:

A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005886
• Other study ID #: CDR0000067956
• Secondary ID: KUMC-7813-99KUMC
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2000
• Last updated: January 12, 2017
• Start date: July 2000
• Est. completion date: August 2002

Study information

• Verified date: January 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• arzoxifene hydrochloride

• tamoxifen citrate

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	U.S. Oncology Research Inc.	Dallas	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Comprehensive Cancer Centers of the Desert	Palm Springs	California
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation