Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
2017年5月27日 更新者：GlaxoSmithKline
A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer
This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer.
Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor.
Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel.
Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.
調査の概要
研究の種類
介入
入学 (実際)
49
段階
- フェーズ2
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
-
-
Florida
-
Miami、Florida、アメリカ、33136
- GSK Investigational Site
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637
- GSK Investigational Site
-
Zion、Illinois、アメリカ、60099
- GSK Investigational Site
-
-
Texas
-
Houston、Texas、アメリカ、77030
- GSK Investigational Site
-
-
-
-
-
London、イギリス、SW3 6JJ
- GSK Investigational Site
-
-
-
-
-
Ramat Gan、イスラエル、52621
- GSK Investigational Site
-
-
-
-
New South Wales
-
Campbelltown、New South Wales、オーストラリア、2560
- GSK Investigational Site
-
Liverpool、New South Wales、オーストラリア、2170
- GSK Investigational Site
-
Randwick、New South Wales、オーストラリア、2031
- GSK Investigational Site
-
-
Queensland
-
South Brisbane、Queensland、オーストラリア、4101
- GSK Investigational Site
-
-
South Australia
-
Bedford Park、South Australia、オーストラリア、5042
- GSK Investigational Site
-
-
Victoria
-
Box Hill、Victoria、オーストラリア、3128
- GSK Investigational Site
-
Ringwood East、Victoria、オーストラリア、3128
- GSK Investigational Site
-
-
-
-
Ontario
-
Toronto、Ontario、カナダ、M4N 3M5
- GSK Investigational Site
-
-
-
-
-
Barcelona、スペイン、08035
- GSK Investigational Site
-
Girona、スペイン、17007
- GSK Investigational Site
-
Valencia、スペイン、46010
- GSK Investigational Site
-
-
-
-
-
Sfax、チュニジア、3000
- GSK Investigational Site
-
Sfax、チュニジア、3029
- GSK Investigational Site
-
Tunis、チュニジア、1007
- GSK Investigational Site
-
Tunis、チュニジア、1004
- GSK Investigational Site
-
-
-
-
-
Auckland、ニュージーランド
- GSK Investigational Site
-
-
-
-
-
Bayonne、フランス、64100
- GSK Investigational Site
-
Lille Cedex、フランス、59020
- GSK Investigational Site
-
Paris cedex 13、フランス、75651
- GSK Investigational 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
全て
説明
Inclusion criteria:
- Tumor accessible for multiple biopsies
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Adequate bone marrow
- Renal and hepatic function
- LVEF (left ventricular ejection fraction) greater than 0% based on ECHO (echocardiogram) or MUGA (multigated acquisition).
Exclusion criteria:
- Females who are pregnant or nursing.
- Any unstable, pre-existing major medical condition.
- Received an investigational drug within the past 4 weeks.
- Had major surgery in the past 2 weeks.
- Currently receiving amiodarone or has received amiodarone in the past 6 months.
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：非ランダム化
- 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：Overall study
A Single arm study with 2 cohorts of participants.
Cohort A consists of participants with tumors overexpressing HER2 and/or EGFR.
Cohort B consists of participants with tumors expressing EGFR without overexpressing HER2.
|
Daily-monotherapy [1500 milligrams (mg)] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
Weekly (80mg/m^2) combination therapy (with daily Lapatinib) for 12 weeks
他の名前：
|
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 pathologic complete response rate (pCR)
時間枠：Week 12
|
pCR was defined as the percentage of participants who achieved an assessment of complete response (CR) following pathologic review of resected tissue.
CR was the disappearance of all target lesions.
Participants in each cohort with unknown or missing response (i.e., those that did not undergo surgery) were included in the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population response was considered to be of special interest.
|
Week 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of participants with pCR that underwent surgical resection
時間枠：Week 12
|
pCR for participants that underwent surgical (surg) resection was defined as the percentage of participants within each cohort who achieved an assessment of CR following pathologic review of resected tissue.
CR was the disappearance of all target lesions.
Participants in each cohort that did not undergo surgical resection were excluded from the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population response was considered to be of special interest.
|
Week 12
|
|
Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])
時間枠：Week 14
|
ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or partial response (PR) at the end of the study divided by the total number of participants enrolled in each cohort.
CR was the disappearance of all target lesions.
PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter.
Each participant's response was based on the investigator assessment of best response using RECIST criteria.
Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population was considered to be of special interest.
|
Week 14
|
|
Percentage of participants with ORR at the end of study (Clinically Evaluable Skin Disease Criteria)
時間枠：Week 14
|
ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or PR at the end of the study divided by the total number of participants enrolled in each cohort.
CR was the disappearance of all target lesions.
PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter.
Each participant's response was based on the investigator assessment of best response using Clinically Evaluable Skin Disease Criteria.
Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage.
From an efficacy standpoint, HER2+ population was considered to be of special interest.
|
Week 14
|
|
Percentage of participants with ORR at the end of study ('Best' of RECIST and Clinically Evaluable Skin Disease Criteria)
時間枠：Week 14
|
ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or PR at the end of the study divided by the total number of participants enrolled in each cohort.
CR was the disappearance of all target lesions.
PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter.
The best response of the participant was defined by the 'Best' combined response (RECIST and Clinically Evaluable Skin Disease Criteria) provided there is no evidence of disease progression.
Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population was considered to be special interest.
|
Week 14
|
|
Percentage of participants with investigator-Assessed Best Response at the end of monotherapy phase (Day 14) (Clinically Evaluable Skin Disease Criteria)
時間枠：Day 14
|
ORR at the end of the monotherapy phase was defined as the percentage of participants within each cohort who had a confirmed CR or PR at the end of lapatinib monotherapy (Day 14) divided by the total number of participants enrolled in each cohort.
CR was the disappearance of all target lesions.
PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter.
Each participant's response was based on the investigator assessment of best response using clinically evaluable skin disease criteria.
Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population was considered to be special interest.
|
Day 14
|
|
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
時間枠：Up to Week 14, surgical resection and post treatment
|
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect, resulted in deterioration in left ventricular cardiac function and caused Grade 3 or 4 interstitial pneumonitis.
|
Up to Week 14, surgical resection and post treatment
|
|
Number of participants with shift from Baseline in hematological toxicity grade
時間枠：Day 14 and up to Week 23, surg resection and post treatment
|
Hematology was summarized for hemoglobin (Hb), platelets, white blood cell count (WBC), neutrophils (Neu), lymphocytes by scheduled assessment and also according to the maximum common terminology criteria (CTC) toxicity grade.
Baseline was the most recent lab value prior to and within two weeks of the first dose of lapatinib.
Change from Baseline was calculated as the value at each visit minus Baseline value.
|
Day 14 and up to Week 23, surg resection and post treatment
|
|
Number of participants with shift from Baseline in clinical chemistry toxicity grade
時間枠：Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment
|
Clinical chemistry was summarized for sodium, potassium (K), bicarbonate (bicarb), albumin (alb), calcium, gamma glutamyl transferase (GGT), creatinine (creat), total bilirubin (TB), alkaline phosphatase (ALP), aspartate amino transferase (AST) and alanine amino transferase (ALT) by scheduled assessment and also according to the maximum CTC toxicity grade.
Baseline was the most recent lab value prior to and within two weeks of the first dose of lapatinib.
Change from Baseline was calculated as the value at each visit minus Baseline value.
|
Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment
|
|
Change from Baseline in vital signs- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
時間枠：Day 14, Week 1 and up to Week 24, surg resection and post treatment
|
Vitals signs (SBP and DBP) were assessed from screening until the post treatment phase.
Baseline was the most recent blood pressure (BP) mean prior to the first dose of lapatinib.
Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
|
Day 14, Week 1 and up to Week 24, surg resection and post treatment
|
|
Change from Baseline in vital signs- Heart Rate (HR)
時間枠：Day 14, Week 1 and up to Week 24, surg resection and post treatment
|
Vitals signs (HR) were assessed from screening until the post treatment phase.
Baseline was the most recent BP mean prior to the first dose of lapatinib.
Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
|
Day 14, Week 1 and up to Week 24, surg resection and post treatment
|
|
Change from Baseline in vital signs- Body temperature
時間枠：Day 14, Week 1 and up to Week 24, surg resection and post treatment
|
Vitals signs (body temperature) were assessed from screening until the post treatment phase.
Baseline was the most recent BP mean prior to the first dose of lapatinib.
Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
|
Day 14, Week 1 and up to Week 24, surg resection and post treatment
|
|
Number of participants with abnormal electrocardiogram (ECG) findings
時間枠：Screening and unscheduled
|
ECG was performed at screening and at unscheduled visits.
Participants with abnormal clinically significant and abnormal not clinically significant ECG findings was reported.
|
Screening and unscheduled
|
|
Number of participants with change from Baseline in echocardiogram (ECHO) or Multi-gated angiogram (MUGA) results at any post Baseline visit
時間枠：Screening, Week 8, 16, 24, post treatment
|
For ECHO and MUGA scans, the left ventricular ejection fraction (percent) was summarized for each scheduled assessment.
Absolute change from Baseline was summarized according to the following categories: any increase, 0 to less than 20 percent decrease, >=20 percent decrease or >=20 percent decrease and below the lower limit of normal (LLN).
Baseline was the most recent ECOG evaluation prior to the first dose of lapatinib.
Change from Baseline was calculated as the value at the post treatment minus Baseline value.
|
Screening, Week 8, 16, 24, post treatment
|
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
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。
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)
2005年4月11日
一次修了 (実際)
2006年11月1日
研究の完了 (実際)
2006年11月1日
試験登録日
最初に提出
2005年5月25日
QC基準を満たした最初の提出物
2005年5月25日
最初の投稿 (見積もり)
2005年5月26日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月31日
QC基準を満たした最後の更新が送信されました
2017年5月27日
最終確認日
2017年5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
- EGF102580
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。
新生物、乳房の臨床試験
-
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