Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00070057
First received: October 3, 2003
Last updated: April 11, 2013
Last verified: April 2013

October 3, 2003
April 11, 2013
April 2003
April 2010   (final data collection date for primary outcome measure)
Change in aromatase activity levels [ Time Frame: From baseline to post-surgery ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00070057 on ClinicalTrials.gov Archive Site
  • Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry [ Time Frame: From baseline to post-treatment ] [ Designated as safety issue: No ]
  • Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens [ Time Frame: At post-treatment/surgery ] [ Designated as safety issue: No ]
  • Effect of treatment vs. no treatment on gene expression (mRNA) profile by microarray, kinase activities (PI3, AKT and ERK1/2 MAP kinases) and PGE2 levels [ Time Frame: At post-treatment/surgery ] [ Designated as safety issue: No ]
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Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer

This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PRIMARY OBJECTIVES:

I. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.

SECONDARY OBJECTIVES:

I. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.

II. Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients.

III. Determine whether any observed biological effect of this drug is dose-dependent in these patients.

IV. Identify collateral targets (COX-2-independent) of this drug in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.

Arm II: Patients receive a higher dose of oral celecoxib as in arm I.

Arm III: Patients do not receive treatment.

All patients undergo definitive surgery.

PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Drug: celecoxib
    Given orally
    Other Names:
    • Celebrex
    • SC-58635
  • Procedure: therapeutic conventional surgery
    Undergo surgery
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
  • Experimental: Arm I (celecoxib)
    Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
    Interventions:
    • Drug: celecoxib
    • Procedure: therapeutic conventional surgery
    • Other: pharmacological study
    • Other: laboratory biomarker analysis
  • Experimental: Arm II (high-dose celecoxib)
    Patients receive a higher dose of oral celecoxib as in arm I.
    Interventions:
    • Drug: celecoxib
    • Procedure: therapeutic conventional surgery
    • Other: pharmacological study
    • Other: laboratory biomarker analysis
  • Active Comparator: Arm III (surgery)
    Patients do not receive treatment. All patients undergo surgery.
    Interventions:
    • Procedure: therapeutic conventional surgery
    • Other: pharmacological study
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Not Provided
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed invasive breast carcinoma

    • Tumor at least 1 cm by radiologic estimate or physical exam
    • No disease limited to ductal carcinoma in situ only
  • Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center
  • Hormone receptor status:

    • Not specified
  • Female
  • Postmenopausal as defined by at least 1 of the following:

    • No menstrual period within the past 12 months
    • Prior bilateral oophorectomy
  • No known liver disease
  • No renal insufficiency
  • No congestive heart failure
  • No coronary artery disease
  • No history of documented peptic ulcer disease
  • No gastritis
  • No medical condition that would preclude definitive surgery
  • No allergy to NSAIDs or sulfa-containing drugs
  • No connective tissue diseases, including any of the following:

    • Systemic lupus erythematosus
    • Reynaud's disease
    • Scleroderma
  • More than 3 months since prior chemotherapy
  • More than 2 weeks since prior hormone replacement therapy
  • More than 2 weeks since prior tamoxifen
  • More than 2 weeks since prior aromatase inhibitors
  • More than 2 weeks since prior raloxifene
  • More than 2 weeks since prior steroids
  • More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
  • More than 1 week since prior cyclooxygenase (COX)-2 inhibitors
  • No concurrent warfarin
  • No concurrent thiazide or loop diuretics
  • No concurrent COX-2 inhibitors
  • No concurrent NSAIDs
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00070057
NCI-2012-01441, MSKCC-03027, CDR0000329919, N01CN35112
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Elisa Port Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP