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

NCT00005886 | Completed Phase 1

• 4 other identifiers: CDR0000067956KUMC-7813-99KUMC-HSC-7419-98NCI-P00-0158
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; ductal breast carcinoma in situ; breast cancer in situ

Interventions

arzoxifene hydrochloride DRUG

tamoxifen citrate DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

U.S. Oncology Research Inc.

Dallas, Texas, 75246, United States

Location

Related 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. doi: 10.1158/1078-0432.CCR-04-0171.

  PMID: 15328178 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Carol J. Fabian, MD

  University of Kansas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: August 29, 2003
• Study Start: July 1, 2000
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

US (9)