このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (EVEREXES)

2020年4月6日 更新者：Novartis Pharmaceuticals

A Phase IIIb, Multi-center, Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

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)

235

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

  • インド
    • Gujarat
      • Karamsad、Gujarat、インド、388325
        • Novartis Investigative Site
    • Maharashtra
      • Nashik、Maharashtra、インド、422 004
        • Novartis Investigative Site
      • Pune、Maharashtra、インド、411013
        • Novartis Investigative Site
    • Orissa
      • Cuttack、Orissa、インド、753 007
        • Novartis Investigative Site
  • インドネシア
      • Bandung、インドネシア、40161
        • Novartis Investigative Site
      • Jakarta、インドネシア、11420
        • Novartis Investigative Site
      • Jogyakarta、インドネシア、55284
        • Novartis Investigative Site
      • Semarang、インドネシア、50212
        • Novartis Investigative Site
  • オーストラリア
    • Australian Capital Territory
      • Garran、Australian Capital Territory、オーストラリア、2605
        • Novartis Investigative Site
    • New South Wales
      • Caringbah、New South Wales、オーストラリア、2229
        • Novartis Investigative Site
      • Liverpool、New South Wales、オーストラリア、2170
        • Novartis Investigative Site
    • Victoria
      • Box Hill、Victoria、オーストラリア、3128
        • Novartis Investigative Site
      • Heidelberg、Victoria、オーストラリア、3084
        • Novartis Investigative Site
      • Ringwood East、Victoria、オーストラリア、3135
        • Novartis Investigative Site
      • St Albans、Victoria、オーストラリア、3021
        • Novartis Investigative Site
  • タイ
      • Bangkok、タイ、10400
        • Novartis Investigative Site
      • Bangkok、タイ、10300
        • Novartis Investigative Site
      • Chiang Mai、タイ、50200
        • Novartis Investigative Site
  • チュニジア
      • Ariana、チュニジア、2080
        • Novartis Investigative Site
  • ベトナム
      • Ho Chi Minh、ベトナム、700000
        • Novartis Investigative Site
  • マレーシア
    • MYS
      • Kuala Lumpur、MYS、マレーシア、56000
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu、Sabah、マレーシア、88586
        • Novartis Investigative Site
    • Wilayah Persekutuan
      • Kuala Lumpur、Wilayah Persekutuan、マレーシア、50586
        • Novartis Investigative Site
  • モロッコ
      • Casablanca、モロッコ
        • Novartis Investigative Site
      • Rabat、モロッコ、6527
        • Novartis Investigative Site
  • ヨルダン
      • Amman、ヨルダン、11941
        • Novartis Investigative Site
  • 七面鳥
      • Ankara、七面鳥、06100
        • Novartis Investigative Site
      • Ankara、七面鳥、06500
        • Novartis Investigative Site
      • Ankara、七面鳥、06460
        • Novartis Investigative Site
      • Gaziantep、七面鳥、27310
        • Novartis Investigative Site
      • Izmir、七面鳥、35040
        • Novartis Investigative Site
      • Kartal、七面鳥、34890
        • Novartis Investigative Site
      • Pendik / Istanbul、七面鳥、34899
        • Novartis Investigative Site
  • 南アフリカ
      • Western Cape、南アフリカ、7925
        • Novartis Investigative Site
    • Western Cape
      • Cape Town、Western Cape、南アフリカ、7925
        • Novartis Investigative Site
      • George、Western Cape、南アフリカ、6530
        • Novartis Investigative Site
  • 台湾
      • Changhua、台湾、50006
        • Novartis Investigative Site
      • Kaohsiung City、台湾、83301
        • Novartis Investigative Site
      • Kaoshiung、台湾、80756
        • Novartis Investigative Site
      • Taipei、台湾、10048
        • Novartis Investigative Site
      • Taipei、台湾、10449
        • Novartis Investigative Site
    • TWN
      • New Taipei City、TWN、台湾、23561
        • Novartis Investigative Site
  • 大韓民国
      • Busan、大韓民国、602739
        • Novartis Investigative Site
      • Jeollanam-do、大韓民国、519763
        • Novartis Investigative Site
      • Seoul、大韓民国、03080
        • Novartis Investigative Site
      • Seoul、大韓民国、06351
        • Novartis Investigative Site
      • Seoul、大韓民国、03722
        • Novartis Investigative Site
      • Seoul、大韓民国、02841
        • Novartis Investigative Site
      • Seoul、大韓民国、06273
        • Novartis Investigative Site
      • Seoul、大韓民国、01812
        • Novartis Investigative Site
      • Taegu、大韓民国、41944
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon、Gyeonggi-do、大韓民国、443380
        • Novartis Investigative Site
    • Korea
      • Gyeonggi do、Korea、大韓民国、10408
        • Novartis Investigative Site
      • Seoul、Korea、大韓民国、05505
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul、Seocho Gu、大韓民国、06591
        • 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:

  • Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
  • Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
  • Disease refractory to non-steroidal aromatase inhibitors, defined as:
  • Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
  • Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
  • Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
  • Patients must have had:

  • At least one lesion that could have been accurately measured in at least one dimension

    • 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
  • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
  • Adequate bone marrow, coagulation, liver and renal function.
  • ECOG performance status ≤ 2.

Exclusion Criteria:

  • Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.
  • Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).
  • Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.
  • Previous treatment with mTOR inhibitors.
  • Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
  • Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.
  • Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
  • History of brain or other CNS metastases, including leptomeningeal metastasis.

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：なし
  • 介入モデル：単一グループの割り当て
  • 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：everolimus + exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily
薬：everolimus
one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1
他の名前：
  • RAD001
薬：exemestane
25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1

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
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
時間枠：Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period
Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Response Rates (Best Overall and Overall)
時間枠：Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
The best overall response for each patient is determined from the sequence of investigator overall lesion responses according to RECIST 1.1: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. To be assigned a best overall response of CR at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best overall response of PR at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Percentage of Participants Clinical Benefit Rate
時間枠：Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Clinical benefit rate: Patients with best overall response rate of CR (any duration), PR (any duration) and SD with duration of 24 weeks or longer according to RECIST 1.1 criteria: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. Best overall response of CR = at least two determinations of CR at least 4 weeks apart before progression are required. Best overall response of PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method.
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries
Progression Free Survival (PFS)
時間枠：Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries

PFS is time from date of start of treatment to date of disease progression or death due to any cause, whichever occurs first.

b Percentiles with 95% CIs are calculated from PROC LIFETEST output using method of Brookmeyer and Crowley (1982)
Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries
Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
時間枠：Baseline up to approximately 50 weeks
Time to deterioration of ECOG performance status, from baseline will be assessed using the ECOG Performance Status Scale (Oken, 1982). Time to deterioration is the time from date of start of treatment to the date of the event defined as deterioration. Deterioration is defined as an increase in performance status from 0 to 2 or greater, an increase in performance status from 1-2 to 3 or greater, or death due to any cause. Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Event-free probability estimates were are obtained from the Kaplan-Meier survival estimates.
Baseline up to approximately 50 weeks

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 (実際)

2013年3月29日

一次修了 (実際)

2019年1月29日

研究の完了 (実際)

2019年1月29日

試験登録日

最初に提出

2017年6月1日

QC基準を満たした最初の提出物

2017年6月1日

最初の投稿 (実際)

2017年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2020年4月7日

QC基準を満たした最後の更新が送信されました

2020年4月6日

最終確認日

2020年4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

  • CRAD001JIC06

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

everolimusの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Japan

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する