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An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer

Phase 1
18 Years
Not Enrolling
Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Thank you

Trial Information

An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer


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


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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in aromatase activity levels

Outcome Time Frame:

From baseline to post-surgery

Safety Issue:


Principal Investigator

Elisa Port

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2003

Completion Date:

Related Keywords:

  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Breast Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021