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Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98

26. juli 2012 oppdatert av: ETOP IBCSG Partners Foundation

Investigating Bone Density and Bone Loss Without Baseline Information

RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.

PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior) region of the spine and hip by assessing bone density in postmenopausal women with breast cancer receiving treatment on protocol IBCSG-1-98.
  • Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2).
  • Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models.
  • Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events.

OUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are assigned to 1 of 3 groups according to the length of treatment they have undergone on protocol IBCSG-1-98.

  • Group 1 (prior to or at the end of the second year of treatment on protocol IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 1, 3, and 4 from baseline.
  • Group 2 (after 2 years but before the end of the third year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 2 and 3 from baseline.
  • Group 3 (after 3 years but before the end of the fifth year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from baseline (for patients in 5th year of treatment).

Patients undergo blood collection at baseline and periodically during study for biomarker correlative study.

PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.

Studietype

Intervensjonell

Registrering (Faktiske)

458

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Institute of Oncology at Prince of Wales Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
  • Frankrike
      • Bordeaux, Frankrike, 33076
        • Institut Bergonié
  • Italia
      • Aviano, Italia, 33081
        • Centro di Riferimento Oncologico - Aviano
      • Bergamo, Italia, 24100
        • Ospedali Riuniti di Bergamo
      • Milano, Italia, 20141
        • European Institute of Oncology
  • New Zealand
      • Dunedin, New Zealand
        • Dunedin Hospital
  • Peru
      • Lima, Peru, 34
        • Instituto Nacional de Enfermedades Neoplasicas
  • Spania
      • Madrid, Spania, 28034
        • Hospital Ruber Internacional
  • Sveits
      • Aarau, Sveits, CH-5001
        • Kantonspital Aarau
      • Bern, Sveits, CH-3010
        • Inselspital Bern
      • Lausanne, Sveits, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Mendrisio, Sveits, CH-6850
        • Ospedale Beata Vergine
      • St. Gallen, Sveits, CH-9007
        • Kantonsspital - St. Gallen
      • Thun, Sveits, 3600
        • Regionalspital
  • Sør-Afrika
      • Cape Town, Sør-Afrika, 7925
        • Groote Schuur Hospital

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

30 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Resected disease

  • Enrolled on protocol IBCSG-1-98

    • Receiving adjuvant endocrine therapy comprising 1 of the following regimens:

      • Letrozole
      • Tamoxifen
      • Letrozole after 2 years of tamoxifen
      • Tamoxifen after 2 years of letrozole
    • Not yet completed 5 years of treatment
  • No breast cancer recurrence or second primary cancer
  • No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta
  • No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy

  • Hormone receptor status:

    • Estrogen receptor-positive and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal
  • No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
  • No malabsorption syndrome or clinically relevant vitamin D deficiency
  • No patients for whom the bone density determination is impossible

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 1 year since prior and no concurrent anticonvulsants
  • More than 6 weeks since prior and no concurrent corticosteroids (at doses > the equivalent of 5 mg/day prednisone) for > 2 weeks total
  • No prior or concurrent sodium fluoride (at daily doses ≥ 5 mg/day) for > 1 month
  • More than 12 months since prior and no concurrent anabolic steroids
  • More than 6 months since prior treatment, either investigational or not, for the prevention of osteoporosis (excluding calcium or cholecalciferol [vitamin D])
  • No concurrent raloxifene
  • Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates allowed
  • Concurrent warfarin allowed provided it is given for ≤ 4 weeks

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tamoxifen 2 år pluss letrozol 3 år
Pasienter behandlet med tamoxifen i 2 år og deretter med letrozol i 3 år.
Annen: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Fremgangsmåte: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Fremgangsmåte: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Eksperimentell: Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomisation.
Annen: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Fremgangsmåte: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Fremgangsmåte: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Eksperimentell: Letrozole for 5 years
Patients treated with letrozole for 5 years after randomisation.
Annen: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Fremgangsmåte: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Fremgangsmåte: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Eksperimentell: Letrozole 2 years plus tamoxifen 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Annen: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Fremgangsmåte: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Fremgangsmåte: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Tidsramme: 5 years after randomisation to BIG 1-98
5 years after randomisation to BIG 1-98
Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98
Tidsramme: 6 years after randomisation to BIG 1-98
6 years after randomisation to BIG 1-98
Proportion of patients with BMD below the absolute threshold value for osteoporosis
Tidsramme: 5 years after randomisation to BIG 1-98
5 years after randomisation to BIG 1-98
Relative percent change in markers of bone resorption from baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
Tidsramme: 5 years after randomisation to BIG 1-98
5 years after randomisation to BIG 1-98
Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98
Tidsramme: 6 years after randomisation to BIG 1-98
6 years after randomisation to BIG 1-98

Samarbeidspartnere og etterforskere

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

Sponsor

ETOP IBCSG Partners Foundation

Etterforskere

  • Studiestol: Stefan Aebi, MD, University Hospital Inselspital, Berne
  • Studiestol: Andrea Decensi, MD, European Institute of Oncology

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. mai 2004

Primær fullføring (Faktiske)

1. mai 2008

Studiet fullført (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først innsendt

24. august 2006

Først innsendt som oppfylte QC-kriteriene

24. august 2006

Først lagt ut (Anslag)

29. august 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. juli 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juli 2012

Sist bekreftet

1. juli 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000482381
  • NOVARTIS-2026703019 (Annen identifikator: Novartis)
  • IBCSG-18-98-BS (Annen identifikator: IBCSG)
  • EU-20623 (Annen identifikator: EU)
  • IBCSG-1-98-BS (Annen identifikator: IBCSG)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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