進行性乳がん患者を対象とした低用量カペシタビンの第II相単群試験
This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.
調査の概要
詳細な説明
The study is a phase II, single arm study in which all patients will receive the study drug. Participants will include older/frail patients with metastatic breast cancer.
All patients will be treated with capecitabine 1000 mg daily. There will be a total of 40 participants with measurable disease on this trial.
The study will encompass participants with locally advanced unresectable/metastatic breast cancer with measurable disease, who progressed on at least 1 prior therapy in the metastatic setting. Breast cancer subtypes include HR+ HER2 negative, or TNBC, age ≥ 60 years old, or frail patients at a younger age. ECOG PS 0- 2.
The study will discontinue if progressive disease or unacceptable toxicity is noted.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Margaret Thomas, MPH
- 電話番号：205-895-1802
- メール：margaretathomas@uabmc.edu
研究連絡先のバックアップ
- 名前：Katia Khouri, MD
- 電話番号：216-556-3035
- メール：katia.khoury@gunet.georgetown.edu
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35294
- 募集
- University of Alabama at Birmingham
-
副調査官：
- Katia Khoury, MD
-
副調査官：
- Gabrielle Rocque, MD
-
コンタクト：
- Humaria Sarfraz, MD
- 電話番号：205-975-2891
- メール：humairasarfraz@uabmc.edu
-
主任研究者：
- Humaria Sarfraz, MD
-
副調査官：
- Mauricio Escobar, MD
-
副調査官：
- Nustrat Jahan, MD
-
副調査官：
- Erica Stringer-Reasor, MD
-
副調査官：
- Allison Richard, MD
-
副調査官：
- Lisle Nabell, MD
-
-
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
Inclusion Criteria:
-
Histologically or cytologically confirmed breast cancer with HER2 negative status. A copy of the pathology report is required at the time of enrollment.
- HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+.
- Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment.
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Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).
-
ECOG performance status of 0-2.
-
Patients must have progressed on at least 1 prior line of therapy in the metastatic setting (hormonal therapy or chemotherapy)
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Adequate organ function as evidenced by:
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ANC >1.5 x 10⁹/L (1500/µL) or > 1.3 x 10⁹/L (1300/µL) for patients with history of benign ethnic neutropenia.
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Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to initiation of study treatment (Cycle 1, day 1)).
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Hemoglobin ≥9.0 g/dl. Patients may be transfused or receive erythropoietic treatment to meet this criterion.
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AST, ALT, and alkaline phosphatase ≤2.5 x upper limit of normal (ULN) with following exceptions: I. Patients with documented liver metastasis: AST and ALT ≤5 x ULN II. Patients with documented liver or bone metastasis: alkaline phosphatase ≤5 x ULN
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Serum bilirubin ≤1.5 x ULN
• Patients with known Gilbert disease who have serum bilirubin level ≤3 x ULN may be enrolled.
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INR and aPTT ≤1.5 x ULN
• This applies only to the patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
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Creatinine clearance > 30 mL/min (measured using Cockcroft-Gault equation or estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study)
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Patients must be able to provide signed informed consent.
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Female patients of any ethnic group. Female patients must be surgically sterile, postmenopausal (no menses for at least one year), or using medically approved method of contraception (excluding rhythm, withdraw or abstinence). Men must agree to use a medically approved method of contraception (excluding rhythm, withdraw or abstinence).
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Patients ≥60 years old and/or frail patients at any age, defined by the investigator as an individual at greater risk of complications and poorer outcomes with systemic therapy, secondary to a lower physiologic reserve and higher comorbidities and functional deficits.
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Complete initial work-up within 2 weeks prior to start of treatment (Cycle 1 Day 1).
-
Patients known to be HIV positive are eligible if they meet the inclusion criteria.
Exclusion Criteria:
- Any history of treatment with Capecitabine in metastatic setting.
- Patients who only have non-measurable disease.
- Patients with severe hepatic (bilirubin > 3 times upper limit of normal) or renal failure (CrCl < 30 calculated using Cockcroft-Gault formula).
- Patients who are unable to swallow pills
- Patients with HER2 positive breast cancer
- Major surgical procedure within 3 weeks prior to study entry.
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >2 weeks prior to initiation of study treatment (Cycle 1, Day 1)
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：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：Low dose capecitabine (Xeloda)
1000 mg capecitabine daily by mouth. |
Will be given once per day by mouth
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 |
|---|---|---|
|
Objective response rate (RR) evaluation
時間枠：Baseline up to 12 weeks
|
Evaluate response rate (RR) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v 1.1). Response and progression of disease will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee; version 1.1. Patients will be evaluated for response every 12 weeks per RECIST Criteria. |
Baseline up to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free survival (PFS)
時間枠：Up to 36 months
|
Initiation of treatment to the occurrence of disease progression or death. The RECIST v. 1.1 criteria will be used to evaluate progression-free survival as well as CT and PET scans. Baseline to the date of first documented progression to date of death from any cause, whichever comes first, assessed up to 36 months. |
Up to 36 months
|
|
Overall survival (OS)
時間枠：Baseline up to 36 months
|
The time which begins at diagnosis (or at the start of treatment) and up to the time of death. |
Baseline up to 36 months
|
|
Number of adverse events
時間枠：Baseline up to 36 months
|
Incidence of Treatment-Emergent Adverse Events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Safety, tolerability, satisfaction, and quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) questionnaire, as well as the PRO-CTCAE (Patient reported outcomes - Common Terminology Criteria for Adverse Events) questionnaire. |
Baseline up to 36 months
|
協力者と研究者
捜査官
- 主任研究者：Humaria Sarfraz, MD、The University of Alabama at Birmingham
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-300012026 (UAB23115)
- Breast Cancer Foundation (その他の識別子：Breast Cancer Foundation)
- Robert Award (その他の識別子：UAB Cancer Center)
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
米国FDA規制機器製品の研究
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