Know Cancer

or
forgot password

Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer


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.).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.

Principal Investigator

Carol J Fabian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

9061

NCT ID:

NCT00328432

Start Date:

June 2003

Completion Date:

December 2005

Related Keywords:

  • Breast Cancer
  • early breast cancer
  • double-blind randomized placebo-controlled
  • RCT
  • pre-surgical model
  • DCIS model
  • COX-2 inhibitor
  • celecoxib
  • Ki-67 placebo
  • Breast Neoplasms

Name

Location

Loyola University Medical CenterMaywood, Illinois  60153
University of Kansas Medical CenterKansas City, Kansas  66160-7353
The Ohio State UniversityColumbus, Ohio  43210
University Of Alabama-BirminghamBirmingham, Alabama  35294
US OncologyHouston, Texas  77060
MDDesert Comprehensive Breast CenterPalm Springs, California  92262
Cleveland Clinical FoundationCleveland, Ohio  44195