NCT00070057

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

6.8 years

First QC Date

October 3, 2003

Last Update Submit

December 28, 2016

Conditions

Stage I Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in aromatase activity levels

    From baseline to post-surgery

Secondary Outcomes (3)

  • Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry

    From baseline to post-treatment

  • Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens

    At post-treatment/surgery

  • 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

    At post-treatment/surgery

Study Arms (3)

Arm I (celecoxib)

EXPERIMENTAL

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

Drug: celecoxibProcedure: therapeutic conventional surgeryOther: pharmacological studyOther: laboratory biomarker analysis

Arm II (high-dose celecoxib)

EXPERIMENTAL

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

Drug: celecoxibProcedure: therapeutic conventional surgeryOther: pharmacological studyOther: laboratory biomarker analysis

Arm III (surgery)

ACTIVE COMPARATOR

Patients do not receive treatment. All patients undergo surgery.

Procedure: therapeutic conventional surgeryOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

celecoxibDRUG

Given orally

Also known as: Celebrex, SC-58635
Arm I (celecoxib)Arm II (high-dose celecoxib)
therapeutic conventional surgeryPROCEDURE

Undergo surgery

Arm I (celecoxib)Arm II (high-dose celecoxib)Arm III (surgery)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm I (celecoxib)Arm II (high-dose celecoxib)Arm III (surgery)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (celecoxib)Arm II (high-dose celecoxib)Arm III (surgery)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Elisa Port

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

April 1, 2003

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

December 29, 2016

Record last verified: 2016-12

Locations

US(1)