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Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer


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
celecoxib as first-line therapy.

Secondary

- Determine the time to disease progression and overall survival of patients treated with
this regimen.

- Determine the toxicity of this regimen in these patients.

- Compare cyclooxygenase activity in blood and tumor cells from these patients before and
after treatment with this regimen.

- Determine the effect of this regimen on aromatase activity, tumor proliferation, and
angiogenesis in tumor samples from these patients.

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Antoinette R. Tan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

040402-4671; CDR0000407502

NCT ID:

NCT00101062

Start Date:

January 2004

Completion Date:

December 2005

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903