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Celecoxib in Treating Women With Metastatic or Recurrent 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: NCT00045591
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : January 11, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer

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

Detailed Description:



  • Compare the progression-free survival of women with metastatic or recurrent breast cancer treated with 2 dose levels of celecoxib.


  • Compare the side effects of the 2 dose levels of this drug in these patients.
  • Compare the overall survival of patients treated with the 2 dose levels of this drug.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to disease status at study entry (complete response vs partial response vs stable) and prior metastatic/recurrent chemotherapy regimens (1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral high-dose celecoxib twice daily.
  • Arm II: Patients receive oral low-dose celecoxib twice daily. In both arms, treatment continues until first disease progression. At disease progression, treatment assignment is unblinded and treatment may continue at the treating physician's discretion. Patients initially randomized to the low-dose arm may either continue on that dosage or crossover to the high-dose arm. Patients initially randomized to the high-dose arm may continue on that dosage. Treatment after disease progression may continue for up to 12 months.

Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

PROJECTED ACCRUAL: A total of 132 patients (88 in the high-dose arm and 44 in the low-dose arm) will be accrued for this study within 22 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design
Study Start Date : February 2003
Actual Primary Completion Date : August 2005
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Celecoxib 100 mg Drug: celecoxib
100 mg PO bid

Experimental: Celecoxib 400 mg Drug: Celecoxib
400 mg PO bid

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 28 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed invasive breast cancer

    • Metastatic or recurrent disease documented by physical or radiographic examination
    • Isolated recurrence of breast cancer not considered eligible
    • Bone disease alone allowed
  • At least 4 prior courses (or 4 months) of chemotherapy resulting in stable disease, partial response, or complete response
  • Treated brain metastases allowed provided all of the following conditions are met:

    • Palliation achieved without evidence of progression for at least 3 months after completion of radiotherapy and/or surgical treatment
    • At least 30 days since prior dexamethasone or other corticosteroids
    • Documentation of another site of metastatic disease (in addition to brain metastases)
  • Measurable or evaluable disease
  • Pleural or peritoneal effusion as only manifestation of disease allowed if palliated by prior chemotherapy
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • CTC (ECOG) 0-2

Life expectancy

  • Not specified


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Albumin at least 3.0 g/dL


  • Creatinine no greater than 1.5 times ULN


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other active malignancy within the past 2 years except nonmelanoma skin cancer
  • No active peptic ulcer disease
  • No known hypersensitivity to sulfonamides, aspirin, or other NSAIDs, including celecoxib


Biologic therapy

  • Concurrent trastuzumab (Herceptin) allowed if initiated at least 3 months prior to study entry


  • See Disease Characteristics
  • At least 6 weeks since prior chemotherapy
  • No more than 2 prior chemotherapy regimens for recurrent or metastatic disease

Endocrine therapy

  • See Disease Characteristics
  • Prior hormonal therapy for metastatic disease allowed
  • No concurrent hormonal therapy except hormones for noncancer-related conditions (e.g., insulin for diabetes)


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • Prior radiotherapy to the breast and for metastatic disease allowed
  • No concurrent palliative radiotherapy


  • See Disease Characteristics


  • Prior adjuvant therapy for metastatic disease allowed
  • Concurrent bisphosphonates allowed
  • Concurrent low-dose aspirin (no greater than 325 mg/day) is allowed
  • No other concurrent therapy with celecoxib or other nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., rofecoxib, aspirin, choline magnesium trisalicylate, ibuprofen, naproxen, etodolac, oxaprozin, diflunisal, nabumetone, or tolmetin)
  • No concurrent fluconazole

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): NCT00045591

Show Show 74 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
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Study Chair: Charles L. Shapiro, MD Ohio State University Comprehensive Cancer Center
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Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00045591    
Other Study ID Numbers: CALGB-40105
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000256905 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action