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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00101062 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: celecoxib Drug: letrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral letrozole once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 45-72 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
Measurable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, as defined by 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No prior endocrine therapy for metastatic disease
Radiotherapy
Surgery
Other
No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 |
Study Chair: | Antoinette R. Tan, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000407502, CINJ-NJ1103, CINJ-5076v3, CINJ-040402, UMDNJ-4761 |
Study First Received: | January 7, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00101062 |
Health Authority: | United States: Federal Government |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent breast cancer |
Celecoxib Skin Diseases Breast Neoplasms |
Letrozole Breast Diseases Recurrence |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Aromatase Inhibitors Central Nervous System Agents |