Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women - Full Text View

Sponsor:	University of Kansas
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00056082

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: celecoxib	Phase II

Study Type:	Interventional
Study Design:	Prevention, Open Label
Official Title:	A Study to Identify Biomarker Modulation by a Cyclooxygenase-2 (COX-2) Inhibitor in Breast Tissue of Premenopausal Women at High Risk for Estrogen Receptor Negative (ERN) Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 2003

Detailed Description:

OBJECTIVES:

Determine the change in proliferation in benign breast epithelial cells as measured by Ki-67/MIB-1 in premenopausal women at high risk for estrogen receptor-negative breast cancer treated with celecoxib.
Determine the feasibility of this regimen by dropout rate of these patients during 12 months of treatment and compliance.
Determine the proportion of these women likely to express cyclooxygenase-2 protein (COX-2) in at least 10% of benign ductal epithelial cells.
Compare the success rate of obtaining adequate ductal epithelial cells by random periareolar fine needle aspiration (FNA) and ductal lavage in these patients before vs after 12 months of a prevention intervention.
Assess pain associated with FNA and ductal lavage in these women.
Correlate, if possible, serum proteomics pattern with cytologic assessment and mammographic density at baseline and at 12 months in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral celecoxib twice daily. Treatment continues for 12 months in the absence of clinical evidence of cancer confirmed by biopsy or unacceptable toxicity.

Patients are assessed at baseline and at 12 months for mammographic breast density, serum hormone levels, and serum IGF-1/IGFBP-3. Patients undergo ductal lavage or fine needle aspiration for assessment of supernatant proteomics and breast biomarkers.

Patients are followed at 2 weeks and then annually for 5 years.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 10-14 months.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056082

Locations

United States, Illinois
Lynn Sage Comprehensive Breast Center at Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7820
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

University of Kansas

National Cancer Institute (NCI)

Investigators

Study Chair:

Carol J. Fabian, MD

University of Kansas

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000271935, KUMC-HSC-8919-02
Study First Received:	March 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00056082 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Breast Neoplasms
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009