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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101062
Recruitment Status : Terminated (study drug unavailable)
First Posted : January 10, 2005
Last Update Posted : June 8, 2011
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey

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 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 or disease Intervention/treatment Phase
Breast Cancer Drug: celecoxib Drug: letrozole Phase 2

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
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 : January 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • 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


  • Granulocyte count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN


  • Creatinine ≤ 1.5 times ULN


  • 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


Biologic therapy

  • Not specified


  • 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


  • See Disease Characteristics
  • See Menopausal status
  • No concurrent radiotherapy


  • See Disease Characteristics
  • See Menopausal status


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00101062

United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Study Chair: Antoinette R. Tan, MD Rutgers Cancer Institute of New Jersey

Additional Information:
Responsible Party: Antionette Tan, MD, UMDNJ/CINJ Identifier: NCT00101062     History of Changes
Other Study ID Numbers: 040402-4671; CDR0000407502
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2005    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Rutgers, The State University of New Jersey:
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents