Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women

NCT00056082 | Completed Phase 2

• 3 other identifiers: KUMC-HSC-8919-02CDR0000271935N01-CN-15135
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing breast cancer in at-risk women. PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing breast cancer in premenopausal women who are at risk of developing cancer.

Conditions

Breast Cancer

Keywords

breast cancer

Study Arms (1)

Celecoxib 400 mg bid

EXPERIMENTAL

Celecoxib 400 mg bid

Drug: celecoxib

Interventions

celecoxib DRUG

Celecoxib daily for 12 months

Also known as: Celebrex

Celecoxib 400 mg bid

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Increased risk for breast cancer on the basis of at least 1 of the following criteria: * Five-year Gail risk at least 1.7% or a calculated risk at least 5 times the average for age group * 20-29 years old - calculated 5-year Gail risk is at least 0.1% * 30-39 years old - calculated 5-year Gail risk is at least 1.0% * 40 and over - calculated 5-year Gail risk is at least 1.7% * Known BRCA1/BRCA2 mutation carrier * Family history consistent with hereditary breast cancer, as defined by any of the following circumstances: * At least 4 relatives with breast cancer at any age * At least 2 first-degree relatives diagnosed with breast cancer at age 50 or younger * Breast and ovarian cancer diagnosed in the same relative * At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer at any age in the same family * Prior biopsy exhibiting atypical hyperplasia, lobular cancer in situ, ductal carcinoma in situ (DCIS)\*, or invasive cancer\*\* NOTE: \*If DCIS or T1a or T1b disease was found, at least 2 months must have elapsed since prior surgery and/or radiotherapy to the involved breast NOTE: \*\*Prior invasive cancer (T1c, T2, or T3) must have been diagnosed at least 2 years before study and be estrogen receptor-negative, node negative * Must have had a random periareolar fine needle aspiration successfully performed within the past 3 months, with at least 1,000 cells on cytology slide and 3 additional slides for biomarker analysis (1 with at least 500 cells for Ki-67 and 2 with at least 100 ductal cells for estrogen receptors and COX-2) * Hormone receptor status: * Estrogen receptor negative PATIENT CHARACTERISTICS: Age * 18 to 55 Sex * Female Menopausal status * Premenopausal, defined as menstrual periods estimated to occur every 21 to 35 days over the past 6 months Performance status * Not specified Life expectancy * At least 5 years Hematopoietic * Absolute granulocyte count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * No bleeding diathesis within the past year Hepatic * Bilirubin no greater than 2.0 mg/dL * Albumin at least 3.0 g/dL * AST and ALT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * No severe liver disease requiring treatment Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * No high blood pressure not controlled by medication * No history of angina * No history of cardiovascular disease * No history of deep vein thrombosis Pulmonary * No history of pulmonary embolism Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergy to sulfa, COX-2 inhibitors, or nonsteroidal anti-inflammatory drugs (NSAIDs) * No history of an ulcer requiring treatment * No history of ulcerative colitis * No inflammatory bowel disease * No body mass index \> 33 * No history of diabetes * No prior metastatic malignancy of any kind * No complications of alcoholism requiring hospitalization * No concurrent asthma being treated PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 6 months since prior chemotherapy Endocrine therapy * At least 6 months since prior antihormone therapy (e.g., selective estrogen-receptor modulators or aromatase inhibitors) * Anticipated use of oral or IV corticosteroids must be less than 2 weeks per year * No change (stop or start) in hormonal therapy within the past 6 months (e.g., estrogen, progesterone, oral contraceptives, or fertility agents) Radiotherapy * See Disease Characteristics * No prior radiotherapy to the contralateral breast involved in the study treatment Surgery * See Disease Characteristics Other * At least 3 weeks since prior aspirin, rofecoxib, celecoxib, other COX-2 inhibitors, or NSAIDs * No concurrent anticoagulants * No other concurrent NSAIDs * No chronic angiotensin-converting enzyme inhibitors * No chronic furosemide\* * No chronic fluconazole\* * No chronic lithium NOTE: \*Occasional concurrent use allowed

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 (3)

Lynn Sage Comprehensive Breast Center at Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7820, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Carol J. Fabian, MD

  University of Kansas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Breast Cancer Prevention Unit

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: January 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2013
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)