Tamoxifen in Preventing Breast Cancer in Women at Increased Risk for Breast Cancer

NCT00096369 | Terminated Phase 2 FDA Drug

• 1 other identifier: CDR0000393444; V-10604
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of tamoxifen may be effective in preventing breast cancer. PURPOSE: This randomized phase II trial is studying tamoxifen to see how well it works compared to placebo in preventing breast cancer in women who are at increased risk for the disease.

Conditions

Breast Cancer

Keywords

breast cancer; lobular breast carcinoma in situ; breast cancer in situ

Outcome Measures

Primary Outcomes (4)

• Plasma levels of hormones and binding proteins as measured by ELISA, IHC, and TUNEL at baseline and 3 months

• Markers of proliferation and apoptosis in breast cells as measured by quantitative MSP at baseline and 3 months

• Promoter-region methylation as assessed by microarrays at baseline and 3 months

• Gene expression

Interventions

tamoxifen citrate DRUG

Eligibility Criteria

• Age: 35 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * At increased risk for breast cancer, as defined by 1 of the following criteria: * Histologically confirmed lobular carcinoma in situ (LCIS) treated by local excision only * Composite increased breast cancer risk of ≥ 1.67% over 5 years, based on the following criteria: * Age * Number of first-degree female relatives with breast cancer * One or more prior breast biopsies * Fine-needle aspiration cytology of a non-cystic lesion in lieu of an open biopsy is considered a biopsy * Prior diagnosis of atypical hyperplasia of the breast * Age at first live birth * Nulliparity * Race * Age at onset of menarche * No prior or suspected invasive breast cancer or ductal carcinoma in situ * No clinical evidence of malignancy by physical examination, including a breast examination within the past 3 months * No evidence of suspicious or malignant disease or uncharacterized lesions on bilateral mammogram within the past 6 months * Normal gynecologic examination, including a bimanual pelvic examination and, if indicated, pap smear within the past 12 months * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 35 and over Sex * Female Menopausal status * Premenopausal and ovulating\*, defined as having regular menses for the past 6 months OR irregular menses with follicular phase (i.e., day 3) follicle-stimulating hormone level \< 20 mIU/mL OR * Postmenopausal NOTE: \* Ovulation is determined by day 21 progesterone level \> 3 ng/mL Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Complete blood count normal * No active bleeding disorder (e.g., qualitative or quantitative platelet abnormality, hemophilia, or von Willebrand's disease) Hepatic * Liver function tests normal Renal * Not specified Cardiovascular * No prior deep-vein thrombosis except a single occurrence related to lower extremity trauma * No prior cerebral vascular accident * No prior transient ischemic attack Pulmonary * No prior pulmonary embolus except a single occurrence related to lower extremity trauma Other * No saline or silicone breast implants * No known allergy to tamoxifen * No macular degeneration * No malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No nonmalignant disease that would preclude administration of tamoxifen * No psychiatric condition, including a history of clinical depression or addictive disorder, that would preclude giving informed consent or study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior systemic adjuvant chemotherapy for LCIS Endocrine therapy * No prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators * At least 3 months since prior and no concurrent use of any of the following drugs: * Estrogen or progesterone replacement therapy * Oral contraceptives * Androgens * Luteinizing hormone-releasing hormone analogs * Prolactin inhibitors * Antiandrogens * Steroids * No concurrent steroids for asthma Radiotherapy * No prior radiotherapy for LCIS Surgery * No prior bilateral prophylactic mastectomy * No prior mastectomy for LCIS Other * Concurrent nonhormonal medications allowed * No concurrent warfarin or cholestyramine * No prior or concurrent participation in any other cancer prevention study * Patients treated with placebo on protocol NSABP-P-1 are eligible

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

Sponsors & Collaborators

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

Study Sites (4)

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• David M. Euhus, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: February 1, 2000
• Primary Completion: March 15, 2007
• Study Completion: March 15, 2007
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

US (4)