Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years (CAPRICE)
2017年10月11日 更新者：SOLTI Breast Cancer Research Group
A Phase II, Open-Label, Multicenter Clinical Trial of Pegylated Liposomal Doxorubicin (Caelyx®) as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease or Age Over 65 Years.
This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity.
The aim of the study is to evaluate the response rate at surgery.
研究概览
详细说明
This is a phase II, uncontrolled, open label, multicenter study of a primary chemotherapy regimen consisting of four cycles of liposomal pegylated doxorubicine 35 mg/m² IV plus cyclophosphamide 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery in breast cancer patients at risk of developing anthracycline-induced cardiotoxicity.
Surgery (tumorectomy, quadrantectomy, or mastectomy plus lymphadenectomy) will be performed 2 to 5 weeks after the last primary chemotherapy infusion.
Patients with > 10% of hormone receptor-positive cells will receive appropriate hormone therapy according to menopausal status.
Patients treated with breast-conserving surgery will receive radiation therapy to the mammary gland.
Patients with T4 tumors or significant axillary involvement (≥ ypN2) will receive radiation therapy to the breast or chest wall and to the lymph node chains.
研究类型
介入性
注册 (实际的)
50
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Barcelona、西班牙、08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona、西班牙、08035
- Hospital Universitari Vall d'Hebron
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Lleida、西班牙、25198
- Hospital Universitari Arnau de Vilanova
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Madrid、西班牙、28041
- Hospital Universitario 12 de Octubre
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Murcia、西班牙、30008
- Hospital Universitario Morales Meseguer
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Barcelona
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L'Hospitalet de Llobregat、Barcelona、西班牙、08907
- Institut Catala d'Oncologia
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Illes Balears
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Palma de Mallorca、Illes Balears、西班牙、07198
- Hospital Son Llatzer
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Tarragona
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Reus、Tarragona、西班牙、42301
- Hospital Universitario Sant Joan de Reus
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically confirmed invasive breast cancer (tumor > 2 cm).
- Estrogen receptor-negative or -weakly positive tumors (less than 50% of cells), as evaluated using IHC.
- Risk factors for developing anthracycline-induced cardiomyopathy.
Exclusion Criteria:
- Severe heart failure (NYHA Class III or IV) .
- Metastatic disease.
- LVEF < 45%.
- Pregnant or breast-feeding patients.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
Primary chemotherapy regimen consisting of four cycles of pegylated-liposomal doxorubicine at 35 mg/m² IV plus CPM 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
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Four cycles of liposomal pegylated doxorubicine at 35 mg/m² IV combined with cyclophosphamide at 600 mg/m² on Day 1 every 4 weeks, and followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Pathological complete response (pCR). pCR is defined as the absence of invasive cancer in the surgical breast specimen. This definition includes evidence of carcinoma in situ only.
大体时间：At surgery.
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At surgery.
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次要结果测量
结果测量 |
大体时间 |
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Clinical response rate (complete plus partial responses). Clinical response will be assessed by imaging using the WHO criteria.
大体时间：Before and after treatment with paclitaxel.
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Before and after treatment with paclitaxel.
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Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy.
大体时间：At surgery.
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At surgery.
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Axillary node involvement after primary chemotherapy.
大体时间：At surgery.
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At surgery.
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Left ventricular ejection fraction measured by echocardiography or MUGA.
大体时间：At baseline, every 2 doxorubicine cycles and before surgery.
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At baseline, every 2 doxorubicine cycles and before surgery.
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Cardiac sign/symptom questionnaire.
大体时间：At baseline, every 2 doxorubicine cycles and before surgery.
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At baseline, every 2 doxorubicine cycles and before surgery.
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Relapse-free survival at 5 years after surgery and overall survival at 5 years after study entry.
大体时间：Until 5 years after surgery.
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Until 5 years after surgery.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅：Miguel Gil, MD、Institut Catala d'Oncologia
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16.
- Gil MJ, Bellet MC, Llombart, Ojeda B, Manso L, Mesia C, Morales S, García-Martinez H, Martínez N, Melé M, Fernández-Ortega A, Baselga J. Pegylated Liposomal Doxorubicin (PLD) as Primary Treatment in Estrogen Receptor (ER) and HER2 Poor Breast Cancer and Risk of Developing Cardiotoxicity or Elderly Patients (pt). Results from the Phase II CAPRICE Study. Cancer Research 71(24 Suppl.): 403s, 2011.(CTRC-AACR San Antonio Breast Cancer Symposium)
- Gil-Gil MJ, Bellet M, Bergamino M, Morales S, Barnadas A, Manso L, Saura C, Fernandez-Ortega A, Garcia-Martinez E, Martinez-Janez N, Mele M, Villagrasa P, Celiz P, Perez Martin X, Ciruelos E, Pernas S. Long-Term Cardiac Safety and Survival Outcomes of Neoadjuvant Pegylated Liposomal Doxorubicin in Elderly Patients or Prone to Cardiotoxicity and Triple Negative Breast Cancer. Final Results of the Multicentre Phase II CAPRICE Study. Front Oncol. 2021 Jul 9;11:645026. doi: 10.3389/fonc.2021.645026. eCollection 2021.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年9月1日
初级完成 (实际的)
2011年2月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2007年11月26日
首先提交符合 QC 标准的
2007年11月26日
首次发布 (估计)
2007年11月27日
研究记录更新
最后更新发布 (实际的)
2017年10月12日
上次提交的符合 QC 标准的更新
2017年10月11日
最后验证
2017年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.