Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer
A Pilot, Phase II, Multicenter, Open-Label, Prospective Evaluation of Docetaxel and Bevacizumab ± Trastuzumab in the First-Line Treatment of Patients With Metastatic Breast Cancer
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT).
All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.
調査の概要
詳細な説明
The study included:
- Study registration on Day 1: Treatment Cycle 1 was initiated within 14 days of signing informed consent
- Treatment was administered in 3 week treatment cycles until the participant developed unacceptable toxicity, had disease progression, withdrew consent, or died
- If participants experienced a complete response (CR), partial response (PR), or stable disease (SD) at Cycle 8 or beyond or had unacceptable toxicity due to docetaxel, they could continue on bevacizumab and/or trastuzumab until they developed unacceptable toxicity, had disease progression, or withdrew consent
- Participants had follow-up assessments within 30 days after discontinuation of treatment with the last of the study drugs for any reason other than death
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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New Jersey
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Bridgewater、New Jersey、アメリカ、08807
- Sanofi-Aventis Administrative Office
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
INCLUSION CRITERIA:
- Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis
- Stage IV disease with at least one measurable lesion according to the RECIST criteria
- HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors
- Life expectancy of >/= 24 weeks
- No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).
- Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750 mg/m^2 epirubicin)
- At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions
- It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated
- Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.
- Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within <2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response
EXCLUSION CRITERIA:
- Prior chemotherapy for metastatic breast cancer
- Prior treatment with bevacizumab or other anti-VEGF therapy
- Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy
- Current or prior history of brain or leptomeningeal metastases
- Presence of neuropathy >/= 2
- Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (>/= Grade 2) peripheral vascular disease
- History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix
- Clinically significant cardiovascular disease
- Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy
- History of bleeding diathesis or coagulopathy
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
- 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 |
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実験的：Docetaxel and Bevacizumab
Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
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Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on
他の名前：
Docetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w
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実験的：Docetaxel, Bevacizumab and Trastuzumab
Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
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Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on
他の名前：
Docetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Progression-free Survival (PFS) Rate: Percentage of Participants With PFS
時間枠：Up to 6 months and 12 months after treatment initiation
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PFS was the time from registration to first documentation of
The Percentage of participants with PFS is reported. For the analysis, participants were censored
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Up to 6 months and 12 months after treatment initiation
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Time to Progression-free Survival (PFS)
時間枠：From treatment initiation to PFS event (up to June 2011)
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Time to PFS was the interval from the date of registration to the earliest of the following documented dates:
Time to PFS was estimated from Kaplan-Meier Plots. |
From treatment initiation to PFS event (up to June 2011)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Confirmed Overall Response (OR) Based on RECIST Criteria
時間枠：From treatment initiation to June 2011
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Confirmed OR was confirmed Complete Response (CR) + confirmed Partial Response (PR). According to RECIST
To determine a response, radiologic tumors assessments were performed using computed tomography (CT) and/or magnetic resonance imaging (MRI) of the chest, and the abdomen, bone scan or positron emission tomography (PET) scan, and other imaging techniques as clinically indicated. To confirm a response, 2 assessments separated by 28 days or more were required. |
From treatment initiation to June 2011
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Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria
時間枠：From treatment initiation to June 2011
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Clinical Benefit (CB) was achieved in participants with a response (CR + PR) or a stable disease (SD). According to RECIST
Confirmation of a response needed 2 responses scored, separated by 28 days or more (for CR and PR), and by 26 weeks or more (for SD). |
From treatment initiation to June 2011
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Duration of Response (DR)
時間枠：From treatment initiation to June 2011
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DR was the interval from date of initial documented confirmed response (CR or PR) to the first documented confirmed date of disease progression (PD) or death from any cause in the absence of previous documentation of objective tumor progression. Participants who were alive and without any record of PD at the time of discontinuation were censored at the last available tumor assessment date; participants with non-study anti-cancer therapy during the study were censored at the last available tumor assessment date prior to the anti-cancer therapy. DR was estimated from Kaplan-Meier Plots. |
From treatment initiation to June 2011
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Overall Survival (OS) Time
時間枠：From treatment initiation to June 2011
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OS was the interval between the date of study entry and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. OS time was estimated from Kaplan-Meier Plots. |
From treatment initiation to June 2011
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Number of Participants With Adverse Events (AE)
時間枠：From treatment initiation to 30 days after the last dose of study treatment
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An adverse event (AE) was any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the clinical study. AEs occurring on or after first dose of study medication inclusive to 30 days post-last dose were the treatment emergent adverse events (TEAEs). An serious adverse event was an AE that at any dose (including overdose) resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly, and/or was medically important. |
From treatment initiation to 30 days after the last dose of study treatment
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Barry Childs, MD、Sanofi
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Bevacizumabの臨床試験
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Weill Medical College of Cornell University終了しました多形性膠芽腫 | 退形成性星細胞腫 | びまん性内因性橋グリオーマ | 脳幹グリオーマ | 毛包粘液性星細胞腫 | 脳幹の神経膠腫 | 脳の線維性星細胞腫 | 混合乏突起膠腫-星細胞腫アメリカ