Clinical trial NCT00328432: A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy
Official title: Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: early breast cancer
double-blind randomized placebo-controlled
RCT
pre-surgical model
DCIS model
COX-2 inhibitor
celecoxib
Ki-67 placebo
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-05-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.

Detailed description: A double blind randomized study of celecoxib 400 mg bid versus placebo in newly diagnosed breast cancer. Assessment of modulation of tissue markers (Ki-67, ER, VEGF, PR, etc.) and serum markers (estradiol, estrone, SHBG, etc.).

Eligibility criteria: Inclusion Criteria:

* women with a recent diagnosis of T1 or T2 non-invasive breast cancer by large core needle or excisional biopsy
* confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post-diagnostic analyses to perform research assessments
* reexcision planned within 10 days to 6 weeks from study start
* if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision

Exclusion Criteria:

* no hormone replacement therapy within the 90 days prior to biopsy
* if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
* no evidence of metastatic malignancy of any kind
* no history of asthma, allergy ASA, NSAIDS, celecoxib or other COX-2 inhibitors for a chronic non-oncological condition with the excision of low dose ASA (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study.
* no celecoxib or rofecoxib use within one month of biopsy
* no history of gastrointestinal ulcer or ulcerative colitis requiring treatment
* no current anticoagulants
* no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study
* no aromatase inhibitor in the six months prior to participation
* no concomitant lithium
* no known significant bleeding disorder

Primary outcomes:
measure: Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.
Secondary outcomes:
measure: Baseline and post-administration assessments of MAP kinase, pERK1 and 2, activated pAKT, change in apotosis indicators, and angiogenesis associated proteins, and Her-2/neu.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Palm Springs
country: United States
facility: MDDesert Comprehensive Breast Center
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Cleveland
country: United States
facility: Cleveland Clinical Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Dallas
country: United States
facility: US Oncology
state: Texas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References: