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S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

13. juli 2018 oppdatert 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

8

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 120 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm I - Celecoxib
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Legemiddel: celecoxib
Gis muntlig
Placebo komparator: Arm II - Placebo
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Annen: placebo
Gis muntlig

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mammographic Density
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ki-67 Expression
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Southwest Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2004

Primær fullføring (Faktiske)

1. juli 2009

Studiet fullført (Faktiske)

1. juli 2009

Datoer for studieregistrering

Først innsendt

4. august 2004

Først innsendt som oppfylte QC-kriteriene

4. august 2004

Først lagt ut (Anslag)

5. august 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2018

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000377698
  • U10CA012027 (U.S. NIH-stipend/kontrakt)
  • U10CA037429 (U.S. NIH-stipend/kontrakt)
  • S0300 (Annen identifikator: SWOG)

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