Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions

9. dubna 2012 aktualizováno: Novartis Pharmaceuticals

A Prospective, Randomized, Multi-center Comparative 2-arm Trial of Efficacy and Safety of Zoledronic Acid (Every 3-months vs. Every 4 Weeks) Beyond Approximately 1 Year of Treatment With Zoledronic Acid in Patients With Bone Lesions From Breast Cancer

The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

430

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Itálie
      • Forlì, Itálie
        • Novartis Investigative Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion criteria:

  • Female patients ≥ 18 years of age.
  • Written informed consent given.
  • Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.
  • Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 .
  • Life expectancy ≥ 1 year.

Exclusion criteria:

  • More than 3 months since last infusion of Zoledronic Acid (Zometa®).
  • Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.
  • Serum creatinine > 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) < 30 mL/min CrCl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dL)])x 0.85
  • Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL ( 3.0 mmol/L).
  • Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
  • Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).
  • History of non-compliance to medical regimens or potential unreliable behavior.
  • Known sensitivity to study drug(s) or class of study drug(s).
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Use of any other investigational agent in the last 30 days.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Every 3 months
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every three months. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized patients will receive a maximum of 4 infusions in this group.
Lék: Zoledronic acid
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.
Ostatní jména:
  • ZOL446
  • Zometa®
Experimentální: Every 4 weeks
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every 4 weeks. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Patients randomized to this group will receive up to 12 infusions.
Lék: Zoledronic acid
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.
Ostatní jména:
  • ZOL446
  • Zometa®

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Annual Overall Skeletal Morbidity Rate (SMR)
Časové okno: 12 months

The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio "days of observation period / 365.25", for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.

SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit.
12 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)
Časové okno: 12 month

Skeletal Related Events (SREs) are defined as a:

  • pathologic bone fracture such as non-vertebral and vertebral compression fractures
  • spinal cord compression identified by positive diagnosis documented by X-ray evidence
  • surgery to bone both curative and prophylactic
  • radiation therapy to bone including palliative, therapeutic or prophylactic
  • hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration.
12 month
Annual Incidence of Any Skeletal Related Events (SREs)
Časové okno: 12 months

Skeletal Related Events (SREs) are defined as a:

  • pathologic bone fracture such as non-vertebral and vertebral
  • spinal cord compression identified by X-rays evidence
  • surgery to bone both curative and prophylactic
  • radiation therapy to bone including palliative, therapeutic or prophylactic
  • hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration. Annual incidence for each SRE was computed in the same way as annual overall SMR.
12 months
Median Time to First Skeletal Related Event(s) (SRE)
Časové okno: 12 month
Median Time to first skeletal related event (SRE) is defined as the time from randomization to the date of first occurrence of any SRE which includes at least one of the following: radiation therapy to bone, pathologic bone fracture, spinal cord compression, surgery to bone, and hypercalcemia of malignancy (HCM). Due to the few numbers of SRE, Kaplan-Meier estimate never reaches a failure probability >=25%; so median time, 25th and 75th percentiles are not determined.For this reason only the estimated percentage of patient SRE free are reported at each time point.
12 month
Percentage of Participants Skeletal Related Event (SRE) Free
Časové okno: 12 months

Percentage of participants SRE free is defined as the Kaplan-Meier estimate of participants free of any Skeletal Related Events(SRE) at each time point.

Skeletal Related Events (SREs) are:

  • pathologic bone fracture; non-vertebral and vertebral
  • spinal cord compression identified by X-rays
  • surgery to bone both curative and prophylactic
  • radiation therapy to bone (palliative, therapeutic or prophylactic)
  • hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level which is symptomatic and requires treatment other than rehydration.
12 months
Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire
Časové okno: At Baseline, Month 3, Month 6, Month 9 and Month 12
Bone pain was assessed by means of a pain score obtained using the Brief Pain Inventory (BPI) questionnaire. The BPI can produce three pain scores: worst pain, a composite pain score, and a pain interference score. The composite pain score, which is the average of questions 3, 4, 5 and 6 of the questionnaire was used in this study. Pain was rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). The outcome is given as the median score for participants at baseline, and 3, 6, 9 and 12 months of treatment
At Baseline, Month 3, Month 6, Month 9 and Month 12
Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value
Časové okno: At Baseline, Month 3, Month 6, Month 9 and Month 12
Pain intensity at rest and on movement is rated by the patient by means of a validated 6-point Verbal Rating Scale (VRS) and refers to the pain which occurred during the last week before the assessment. Median score value is the median of all the observed scores (none=0, very mild=1, mild=2, moderate=3, severe=5 and very severe=6) at each time point.
At Baseline, Month 3, Month 6, Month 9 and Month 12
Use Of Analgesic Medications According to the Analgesic Score Scale
Časové okno: At Baseline, Month 3, Month 6, Month 9 and Month 12

The analgesic score used for this study is modified from the Radiation Therapy Oncology Group (RTOG) analgesic score scale. The scale represents type of medication administered from 0 to 4 where:

0 = None

  1. = Minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.)
  2. = Tranquilisers, antidepressants, muscle relaxants, and steroids
  3. = Mild narcotics (oxycodone, meperidine, codeine, etc.)
  4. = Strong narcotics (morphine, hydromorphone, etc.) The outcome is given a the median score for the participants at Baseline and 3, 6, 9 and 12 months of treatment
At Baseline, Month 3, Month 6, Month 9 and Month 12
Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score
Časové okno: At Baseline, Month 3, Month 6, Month 9 and Month 12
ECOG Performance Score has 4 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. Outcome is given as median score for participants at Baseline and 3, 6 , 9 and 12 months of treatment
At Baseline, Month 3, Month 6, Month 9 and Month 12

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novartis Pharmaceuticals

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2006

Primární dokončení (Aktuální)

1. února 2010

Termíny zápisu do studia

První předloženo

12. září 2006

První předloženo, které splnilo kritéria kontroly kvality

12. září 2006

První zveřejněno (Odhad)

13. září 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

11. dubna 2012

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. dubna 2012

Naposledy ověřeno

1. července 2011

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CZOL446EIT14

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Zoledronic acid

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Mexico

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit