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Celecoxib and Trastuzumab in Treating Women With 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: NCT00006381
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Celecoxib may be effective in preventing the further development of cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining trastuzumab with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and trastuzumab in treating women who have metastatic breast cancer that has not responded to previous trastuzumab.

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

Detailed Description:


  • Determine the efficacy of celecoxib and trastuzumab (Herceptin) in women with HER2/neu-overexpressing metastatic breast cancer that is refractory to prior trastuzumab.
  • Determine the safety of celecoxib in these patients.

OUTLINE: At least 3 weeks after the last dose of prior chemotherapy, patients receive oral celecoxib twice daily. Patients continue or restart trastuzumab (Herceptin) IV over 30-90 minutes weekly or every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within approximately 9 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study of Celecoxib in HER-2/Neu Overexpressing Metastatic Breast Cancer Patients Who Have Failed Recombinant Humanized Anti-p 185HER Monoclonal Antibody Trastuzumab (HERCEPTIN)
Study Start Date : June 2000
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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


  • Histologically proven metastatic breast cancer

    • HER2/neu-positive (overexpressing) tumor tissue
  • Failed prior trastuzumab (Herceptin) therapy with or without chemotherapy
  • Resected stage IV disease allowed if evidence of disease
  • Bidimensionally measurable or evaluable disease

    • No lesions in previously irradiated field except nonbone lesions progressive after radiotherapy
    • No pleural effusions
    • No blastic or mixed bony metastases
    • No palpable abdominal masses
  • No leptomeningeal disease
  • Brain metastases allowed if:

    • No concurrent use of steroids
    • At least 3 months since prior brain irradiation
    • No evidence of progression of metastases
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


  • Granulocyte count at least 1,500/mm^3
  • Hemoglobin at least 8.0 g/dL
  • Platelet count at least 100,000/mm^3


  • AST/ALT no greater than 2 times upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN


  • Creatinine no greater than 1.5 mg/dL


  • LVEF at least 50%


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No other serious medical illness
  • No severe infection
  • No severe malnutrition
  • No prior allergic reactions to sulfonamides or celecoxib


Biologic therapy:

  • See Disease Characteristics
  • Prior trastuzumab (Herceptin) for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior cytotoxic therapy for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease

Endocrine therapy:

  • See Disease Characteristics
  • At least 3 weeks since prior hormonal therapy
  • Prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy allowed


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior localized radiotherapy allowed if no influence on the signal measurable lesion
  • Concurrent localized radiotherapy allowed if no influence on the signal measurable lesion


  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered
  • At least 2 weeks since prior minor surgery and recovered

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): NCT00006381

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Chau T. Dang, MD Memorial Sloan Kettering Cancer Center

Layout table for additonal information Identifier: NCT00006381     History of Changes
Other Study ID Numbers: CDR0000068255
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2003

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
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