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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070057 |
Purpose
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: celecoxib Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Study of COX-2 Inhibition and Aromatase Activity in Breast Cancer |
| Study Start Date: | April 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast carcinoma
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal as defined by at least 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
No connective tissue diseases, including any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Elisa Rush Port, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Clifford A. Hudis, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000329919, MSKCC-03027 |
| Study First Received: | October 3, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00070057 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
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Anti-Inflammatory Agents Celecoxib Skin Diseases Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Breast Neoplasms |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Breast Diseases |
|
Anti-Inflammatory Agents Celecoxib Skin Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Breast Neoplasms Enzyme 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 |