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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

458

Fas

  • Fas 3

Kontakter och platser

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

Studieorter

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

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

30 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Tamoxifen 2 år plus letrozol 3 år
Patienter som behandlats med tamoxifen i 2 år och därefter med letrozol i 3 år.
Övrig: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Procedur: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Procedur: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Experimentell: Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomisation.
Övrig: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Procedur: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Procedur: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Experimentell: Letrozole for 5 years
Patients treated with letrozole for 5 years after randomisation.
Övrig: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Procedur: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Procedur: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Experimentell: Letrozole 2 years plus tamoxifen 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Övrig: laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Procedur: Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Procedur: Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 years after randomisation to BIG 1-98
6 years after randomisation to BIG 1-98

Samarbetspartners och utredare

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

Sponsor

ETOP IBCSG Partners Foundation

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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 maj 2004

Primärt slutförande (Faktisk)

1 maj 2008

Avslutad studie (Faktisk)

1 januari 2012

Studieregistreringsdatum

Först inskickad

24 augusti 2006

Först inskickad som uppfyllde QC-kriterierna

24 augusti 2006

Första postat (Uppskatta)

29 augusti 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

27 juli 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 juli 2012

Senast verifierad

1 juli 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

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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