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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 1

Conditions

Stage IIIA Breast Cancer

Stage IIIB Breast Cancer

Stage IIIC Breast Cancer

Stage II Breast Cancer

Stage I Breast Cancer

Treatments

Procedure: therapeutic conventional surgery

Other: laboratory biomarker analysis

Drug: celecoxib

Other: pharmacological study

Study type

Interventional

Funder types

NIH

Identifiers

NCT00070057

NCI-2012-01441 (Registry Identifier)

CDR0000329919

P30CA008748 (U.S. NIH Grant/Contract)

N01-CN-35112 (Other Identifier)

N01CN35112 (Other Grant/Funding Number)

MSKCC-03027 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

75 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

Arm I (celecoxib)

Experimental group

Description:

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

Treatment:

Other: pharmacological study

Drug: celecoxib

Other: laboratory biomarker analysis

Procedure: therapeutic conventional surgery

Arm II (high-dose celecoxib)

Experimental group

Description:

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

Treatment:

Other: pharmacological study

Drug: celecoxib