Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib; Letrozole

Criteria

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