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S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

13 juli 2018 uppdaterad av: Southwest Oncology Group

Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.

PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

OBJECTIVES:

  • Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo.
  • Compare 1-year proliferation of breast epithelial cells, as measured by Ki67 staining, in patients treated with these drugs.
  • Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs.
  • Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E_2 in patients treated with these drugs.
  • Compare the toxicity of these drugs in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but < 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Celocoxib: Patients receive oral celecoxib twice daily.
  • Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Studietyp

Interventionell

Inskrivning (Faktisk)

8

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Glendale, California, Förenta staterna, 91204
        • Glendale Memorial Hospital Comprehensive Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87131-5636
        • University of New Mexico Cancer Center
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Ben Taub General Hospital
      • Houston, Texas, Förenta staterna, 77030
        • Methodist Hospital
      • Houston, Texas, Förenta staterna, 77030
        • Veterans Affairs Medical Center - Houston
      • Houston, Texas, Förenta staterna, 77030
        • Baylor University Medical Center - Houston
      • Houston, Texas, Förenta staterna, 77030
        • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
    • Washington
      • Seattle, Washington, Förenta staterna, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Förenta staterna, 98195-6043
        • University Cancer Center at University of Washington Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 120 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

DISEASE CHARACTERISTICS:

  • At elevated risk of developing breast cancer, as defined by 1 of the following:

    • Modified Gail risk at 5 years ≥ 1.7% or lifetime risk ≥ 20% AND Claus Model, BRCAPro Model, or Tyrer-Cuzick Model lifetime risk ≥ 20%
    • Diagnosis of lobular carcinoma in situ or ductal carcinoma in situ
    • Known deleterious mutation of BRCA1 or BRCA2
  • At least 1 breast available for imagery and biopsy

  • Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry

    • Mammogram normal or benign (BIRADS score 0 or 1)

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Premenopausal, defined by 1 of the following criteria:

    • Last menstrual period < 6 months ago AND no prior bilateral ovariectomy AND not on estrogen replacement therapy
    • Prior hysterectomy (with ovaries still in place) AND normal follicle-stimulating hormone levels within 28 days of study entry

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin < 2.0 times institutional upper limit of normal (IULN)
  • SGOT or SGPT < 2 times IULN
  • Alkaline phosphatase < 2 times IULN
  • INR ≤ 1.5
  • PT and PTT ≤ IULN

Renal

  • Serum creatinine < 2.0 times IULN

Cardiovascular

  • No history of myocardial infarction
  • No angina pectoris
  • No known coronary artery disease
  • No history of stroke or mini-stroke (e.g., transient ischemic attack)
  • No history of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)
  • No uncontrolled hypertension (i.e., blood pressure > 140/90 mmHg)

Pulmonary

  • No asthma after taking aspirin or other NSAIDs

Other

  • No known sensitivity to celecoxib
  • No allergy to sulfonamides
  • No urticaria or allergic-type reactions after taking aspirin or other NSAIDs
  • No extreme lactose intolerance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or early bladder cancer (preinvasive transitional cell carcinoma of the bladder)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 5 years since prior biologic therapy for cancer

Chemotherapy

  • More than 5 years since prior chemotherapy for cancer

Endocrine therapy

  • At least 28 days since prior tamoxifen
  • No prior systemic estrogen modifiers (SERMs) or aromatase inhibitors
  • Concurrent hormonal contraception (i.e., pills, patches, or shots) allowed provided contraception was initiated prior to study entry

Radiotherapy

  • No prior radiotherapy to the breast to be studied

Surgery

  • Not specified

Other

  • At least 7 days since prior anticoagulant therapy

  • More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration

    • Concurrent intermittent aspirin or NSAIDs allowed (no more than 10 days per month)
  • No concurrent participation in another clinical trial for treatment or prevention of cancer unless no longer receiving treatment and is in the follow-up phase

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm I - Celecoxib
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Läkemedel: celecoxib
Ges oralt
Placebo-jämförare: Arm II - Placebo
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Övrig: placebo
Ges oralt

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mammographic Density
Tidsram: 1 year
The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.
1 year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ki-67 Expression
Tidsram: 1 year
The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).
1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Southwest Oncology Group

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Studiestol: Powel H. Brown, MD, PhD, Baylor College of Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2004

Primärt slutförande (Faktisk)

1 juli 2009

Avslutad studie (Faktisk)

1 juli 2009

Studieregistreringsdatum

Först inskickad

4 augusti 2004

Först inskickad som uppfyllde QC-kriterierna

4 augusti 2004

Första postat (Uppskatta)

5 augusti 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juli 2018

Senast verifierad

1 juli 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CDR0000377698
  • U10CA012027 (U.S.S. NIH-anslag/kontrakt)
  • U10CA037429 (U.S.S. NIH-anslag/kontrakt)
  • S0300 (Annan identifierare: SWOG)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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