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

2012年4月9日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

430

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イタリア
      • Forlì、イタリア
        • Novartis Investigative Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
他の名前：
  • ZOL446
  • ゾメタ®
実験的：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.
薬：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.
他の名前：
  • ZOL446
  • ゾメタ®

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Annual Overall Skeletal Morbidity Rate (SMR)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis Pharmaceuticals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2006年2月1日

一次修了 (実際)

2010年2月1日

試験登録日

最初に提出

2006年9月12日

QC基準を満たした最初の提出物

2006年9月12日

最初の投稿 (見積もり)

2006年9月13日

学習記録の更新

投稿された最後の更新 (見積もり)

2012年4月11日

QC基準を満たした最後の更新が送信されました

2012年4月9日

最終確認日

2011年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CZOL446EIT14

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