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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Collaborator: |
University of Arizona |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00245024 |
Purpose
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent breast cancer.
PURPOSE: This randomized phase I trial is studying the effects of sulindac, to prevent breast cancer, in women at high risk for breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: sulindac Other: laboratory biomarker analysis |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase IB Sulindac Study for Women at High Risk for Breast Cancer |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2005 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label study.
Patients undergo nipple aspirate fluid (NAF) collection. Patients are then randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Negative mammogram for breast cancer within the past 10 months
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| Study Chair: | Patricia Thompson, PhD | University of Arizona |
More Information
| Responsible Party: | H. H. Sherry Chow, Arizona Cancer Center at University of Arizona Health Science Center |
| ClinicalTrials.gov Identifier: | NCT00245024 History of Changes |
| Other Study ID Numbers: | CDR0000447144, P30CA023074, UARIZ-UAZ04-2-02, UARIZ-HSC-0553 |
| Study First Received: | October 25, 2005 |
| Last Updated: | October 3, 2011 |
| Health Authority: | United States: Federal Government |
|
breast cancer ductal breast carcinoma in situ lobular breast carcinoma in situ breast cancer in situ |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Sulindac Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cyclooxygenase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |