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Home > "T" Clinical Trials Conditions > Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer  Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
For Condition: breast cancer in situ,stage 1 breast cancer,stage 2 breast cancer,intraductal breast carcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Kansas
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the uptake of estrogen. PURPOSE: Randomized phase I trial to compare the effectiveness of tamoxifen with that of LY353381 in treating women who have newly diagnosed breast cancer.
Details: OBJECTIVES: I. 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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) --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 --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/mm3; Hemoglobin greater than 10 g/dL; Absolute granulocyte count greater than 1,000/mm3 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolFabian, Study Chair, University of Kansas
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
U.S. Oncology Research Inc.
Dallas, Texas, 75246
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: CDR0000067956; KUMC-7813-99,NCI-P00-0158,KUMC-HSC-7419-98
Study Start Date: July 2000
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005886
Other Breast Cancer In Situ Studies:
1. Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole
2. Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer Who Are Eligible For Tamoxifen Therapy
3. Medroxyprogesterone in Treating Women With Breast Cancer
4. Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer
5. Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
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Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
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