Observation Only Study Involving Participants Enrolled in the CHAT Trial
Follow-Up Observational Study In CHAT Trial Participants With Advanced And/Or Metastatic Breast Cancers That Overexpress HER2, Who Were Randomised To Receive Trastuzumab And Docetaxel With Or Without Capecitabine
The aim of the CHAT study ("An open-label, randomized Phase II study of Herceptin (trastuzumab), Taxotere® (docetaxel) and Xeloda (capecitabine) in combination, versus Herceptin (trastuzumab) plus Taxotere® (docetaxel), in patients with advanced and/or metastatic breast cancers that overexpress HER2") was to test the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer.
Overall Response Rate was the primary endpoint of the CHAT study. This study failed to meet its primary objective of showing a difference between the treatment groups, with equivalent high response rates for the Trastuzumab plus Docetaxel and Trastuzumab, Docetaxel plus capecitabine arms.
Secondary endpoints in the CHAT study were Progression-Free-Survival, Time-to-Progression, Overall Survival, duration of response and safety profile. Whilst analysis of the existing data is consistent with improvement with the triplet therapy, interpretation is compromised by the relatively short median follow-up of 24 months. In hindsight the statistical design was flawed by selection of a sub optimal primary endpoint and consequently data was collected and analysed early in relation to time-dependent endpoints. Beyond CHAT will permit capture of mature data for time-related endpoints. Time-to-Progression and Overall Survival are the co-primary endpoints for the Beyond CHAT protocol. The impact of treatment following the first progression, on survival, will be explored.
Time-to-Progression will be defined from the time interval between the date of randomisation and the occurrence of progressive disease under therapy according to RECIST criteria.
Overall Survival will be defined as the time from date of randomisation to date of death
調査の概要
状態
条件
詳細な説明
The objective of this study is to gain mature data on the long-term efficacy of the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer.
The study also aims to gain information on the additional treatments and sequencing used in patients that have progressed following the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer.
Overall Survival data on patients who have progressed following the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer will also be analysed and reported.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Victoria
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Geelong、Victoria、オーストラリア、3220
- CONTACT Asia Pacific
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- CHAT trial participants whose data was used in the final data analysis for the CHAT study
Exclusion Criteria:
- Any patients who have withdrawn consent to the CHAT study
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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CHAT trial participants
CHAT trial participants whose data was used in the final data analysis for the CHAT study
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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 |
時間枠 |
---|---|
The primary endpoints are Time-to-Progression and Overall Survival in the two treatment arms of the CHAT study.
時間枠:survival
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survival
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二次結果の測定
結果測定 |
時間枠 |
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全生存
時間枠:7年間
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7年間
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Progression-Free-Survival
時間枠:7 years
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7 years
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Anatomical sites of progression
時間枠:7 years
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7 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Richard Bell, MBBS、CONTACT Asia Pacific
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
乳がんの臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
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