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

28. december 2016 opdateret af: National Cancer Institute (NCI)

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

75

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan-Kettering Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I (celecoxib)
Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
Andet: laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: farmakologisk undersøgelse
Korrelative undersøgelser
Andre navne:
  • farmakologiske undersøgelser
Procedure: terapeutisk konventionel kirurgi
Gennemgå operation
Medicin: celecoxib
Gives oralt
Andre navne:
  • Celebrex
  • SC-58635
Eksperimentel: Arm II (high-dose celecoxib)
Patients receive a higher dose of oral celecoxib as in arm I.
Andet: laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: farmakologisk undersøgelse
Korrelative undersøgelser
Andre navne:
  • farmakologiske undersøgelser
Procedure: terapeutisk konventionel kirurgi
Gennemgå operation
Medicin: celecoxib
Gives oralt
Andre navne:
  • Celebrex
  • SC-58635
Aktiv komparator: Arm III (surgery)
Patients do not receive treatment. All patients undergo surgery.
Andet: laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: farmakologisk undersøgelse
Korrelative undersøgelser
Andre navne:
  • farmakologiske undersøgelser
Procedure: terapeutisk konventionel kirurgi
Gennemgå operation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in aromatase activity levels
Tidsramme: From baseline to post-surgery
From baseline to post-surgery

Sekundære resultatmål

Resultatmål
Tidsramme
Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry
Tidsramme: From baseline to post-treatment
From baseline to post-treatment
Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens
Tidsramme: At post-treatment/surgery
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
Tidsramme: At post-treatment/surgery
At post-treatment/surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Elisa Port, Memorial Sloan Kettering Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2003

Primær færdiggørelse (Faktiske)

1. februar 2010

Studieafslutning (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først indsendt

3. oktober 2003

Først indsendt, der opfyldte QC-kriterier

6. oktober 2003

Først opslået (Skøn)

7. oktober 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2012-01441 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P30CA008748 (U.S. NIH-bevilling/kontrakt)
  • CDR0000329919
  • MSKCC-03027 (Anden identifikator: Memorial Sloan-Kettering Cancer Center)
  • N01-CN-35112 (Anden identifikator: DCP)
  • N01CN35112 (Andet bevillings-/finansieringsnummer: US NIH Grant/Contract Award Number)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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