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A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread (MONARCH 1)

2020年1月10日 更新者：Eli Lilly and Company

A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

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)

132

段階

  • フェーズ2

アクセスの拡大

利用可能 臨床試験外。 拡張アクセス記録をご覧ください。

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

  • アメリカ
    • Arizona
      • Sedona、Arizona、アメリカ、86336
        • Northern Arizona Hematology & Oncology Associates
      • Tucson、Arizona、アメリカ、85715
        • Arizona Clinical Research Center
      • Tucson、Arizona、アメリカ、85704
        • HOPE Hematology Oncology Physicians and Extenders
    • California
      • San Francisco、California、アメリカ、94115
        • Univ of California San Francisco
      • Santa Barbara、California、アメリカ、93105
        • Sansum Medical Research Foundation
    • Colorado
      • Denver、Colorado、アメリカ、80220
        • Rocky Mountain Cancer Center
    • District of Columbia
      • Washington、District of Columbia、アメリカ、20010
        • Washington Hospital Center
    • Florida
      • Fort Myers、Florida、アメリカ、33916
        • Florida Cancer Specialists
      • Miami、Florida、アメリカ、33176
        • Advanced Medical Specialties
      • Saint Petersburg、Florida、アメリカ、33705
        • Florida Cancer Specialists
    • Maryland
      • Columbia、Maryland、アメリカ、21044
        • Maryland Oncology Hematology, P.A.
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • Dana Farber Cancer Institute
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55404
        • Minnesota Oncology/Hematology PA
    • New York
      • New York、New York、アメリカ、10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cincinnati、Ohio、アメリカ、45242
        • Oncology Hematology Care Inc
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • Sarah Cannon Research Institute SCRI
    • Texas
      • Austin、Texas、アメリカ、78731
        • Texas Oncology Cancer Center
      • Bedford、Texas、アメリカ、76022
        • Texas Oncology - Bedford
      • Dallas、Texas、アメリカ、75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Dallas、Texas、アメリカ、75231
        • Presbyterian Hospital Dallas
      • Fort Worth、Texas、アメリカ、76104
        • The Center for Cancer and Blood Disorders
      • Houston、Texas、アメリカ、77024
        • Texas Oncology-Memorial City
      • Plano、Texas、アメリカ、75093
        • Texas Oncology-Plano West
      • Sherman、Texas、アメリカ、75090-0504
        • Texas Oncology-Sherman
      • The Woodlands、Texas、アメリカ、77380
        • US Oncology
      • Tyler、Texas、アメリカ、75702
        • Tyler Cancer Center
    • Washington
      • Vancouver、Washington、アメリカ、98684
        • Northwest Cancer Specialists PC
  • スペイン
      • Barcelona、スペイン、08035
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Madrid、スペイン、28007
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valencia、スペイン、46015
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • フランス
      • Dijon、フランス、21034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Paris、フランス、75248
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • ベルギー
      • Brussel、ベルギー、1000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Charleroi、ベルギー、6000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Leuven、ベルギー、3000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Liège、ベルギー、4000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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.

  • Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
  • Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.

  • Prior treatment with at least 2 chemotherapy regimens:

    • At least 1 of these regimens must have been administered in the metastatic setting.
    • At least 1 of these regimens must have contained a taxane.
    • No more than 2 prior chemotherapy regimens in the metastatic setting.
  • Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
  • Have discontinued all previous therapies for cancer.
  • Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.

Exclusion Criteria:

  • Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
  • Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
  • Have had major surgery within 14 days of the initial dose of study drug.
  • Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

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：Abemaciclib
200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
薬：アベマシクリブ
経口投与
他の名前：
  • LY2835219

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
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
時間枠：From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS)
時間枠：From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
Duration of Response (DOR)
時間枠：From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Progression Free Survival (PFS)
時間枠：From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])
時間枠：From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)
時間枠：From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score
時間枠：Cycle 6 Day 1
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Cycle 6 Day 1
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20
時間枠：Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20
Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score
時間枠：Cycle 6 Day 1
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Cycle 6 Day 1

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

Eli Lilly and Company

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2014年6月10日

一次修了 (実際)

2016年4月30日

研究の完了 (実際)

2018年10月22日

試験登録日

最初に提出

2014年3月31日

QC基準を満たした最初の提出物

2014年3月31日

最初の投稿 (見積もり)

2014年4月3日

学習記録の更新

投稿された最後の更新 (実際)

2020年1月21日

QC基準を満たした最後の更新が送信されました

2020年1月10日

最終確認日

2020年1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

  • 15419
  • I3Y-MC-JPBN (その他の識別子：Eli Lilly and Company)
  • 2013-005548-27 (その他の識別子：EudraCT Number)

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

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD 共有時間枠

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD 共有アクセス基準

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • CSR

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。

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