Status:
TERMINATED
Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 growt...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in postmenopausal women with hormone receptor-positive locally advanced or metastatic adenocarcinoma of the breast treated with letrozole and celeco...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Locally advanced or metastatic disease
- Measurable disease
- No bone disease only
- No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry
- Hormone receptor status:
- Estrogen receptor- OR progesterone receptor-positive
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Postmenopausal, as defined by 1 of the following:
- Prior bilateral oophorectomy
- Prior bilateral ovarian irradiation
- No spontaneous menstrual bleeding within the past 12 months
- Age 55 and over AND prior hysterectomy without oophorectomy
- Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range
- Performance status
- ECOG 0-2
- Life expectancy
- At least 3 months
- Hematopoietic
- Granulocyte count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN
- Other
- No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
- No prior allergic reaction to sulfonamides
- No active peptic ulcer disease
- No active infection
- No other medical condition that would preclude study participation
- Able to swallow oral medication
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for metastatic or recurrent disease
- Endocrine therapy
- No prior endocrine therapy for metastatic disease
- Prior adjuvant tamoxifen allowed
- No prior aromatase inhibitors
- No prior hormonal therapy for recurrent disease
- No other concurrent hormonal therapy
- Radiotherapy
- See Disease Characteristics
- See Menopausal status
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
- See Menopausal status
- Other
- No concurrent fluconazole or lithium
- No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors
- Concurrent chronic cardioprotective low-dose aspirin allowed
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00101062
Start Date
January 1 2004
End Date
December 1 2005
Last Update
June 8 2011
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903