Multicenter Descriptive Study of the Patient Clinical Profile That Begins With Disseminated Her 2 + Breast Cancer or Develops a Metastasis After or During the Adjuvant Therapy (PRIMHER)
Observational, Cross-sectional, Multicenter Descriptive Study of the Patient Clinical Profile That Begins With Disseminated Her 2 + Breast Cancer or Develops a Metastasis After or During the Adjuvant Therapy (PRIMHER)
This is an observational, cross-sectional study that the main objective is to describe the patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a metastasis after or during the adjuvant treatment.
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
129
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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Almería、西班牙、04009
- Hospital de Torrecardenas
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Badajoz、西班牙、06008
- Hospital Infanta Cristina de Badajoz
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Barcelona、西班牙、08017
- Clínica Corachan
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Ciudad Real、西班牙、13005
- Complejo Hospitalario Ciudad Real
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Cáceres、西班牙、10003
- Hospital San Pedro Alcántara
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León、西班牙、24008
- Hospital de León
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Lleida、西班牙、25198
- Hospital Universitario Arnau de Vilanova
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Lugo、西班牙、27003
- Hospital Lucus Augusti
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Madrid、西班牙、28006
- Hospital La Princesa
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Murcia、西班牙、30008
- Hospital Morales Messeguer
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Segovia、西班牙、40002
- Hospital General de Segovia
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Sevilla、西班牙、41009
- Hospital Virgen de la Macarena
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Valencia、西班牙、46014
- Hospital General Universitario de Valencia
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Valencia、西班牙、46017
- Hospital Dr.Peset
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Valladolid、西班牙、47012
- Hospital Universitario Río Hortega
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Valladolid、西班牙、47005
- Hospital Clínico de Valladolid
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Zamora、西班牙、49021
- Hospital de Zamora
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Alicante
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Denia、Alicante、西班牙、03700
- Hospital de Denia
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Elda、Alicante、西班牙、03600
- Hospital General de Elda
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Asturias
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Gijón、Asturias、西班牙、33203
- Hospital de Cabueñes
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Badajoz
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Don Benito、Badajoz、西班牙、06400
- Hospital don Benito
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Llerena、Badajoz、西班牙、06900
- Hospital de Llerena
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Mérida、Badajoz、西班牙、06800
- Hospital de Mérida
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Barcelona
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Badalona、Barcelona、西班牙、08916
- Ico Badalona
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Hospitalet de Llobregat、Barcelona、西班牙、08906
- Hospital General de l'Hospitalet
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Cáceres
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Plasencia、Cáceres、西班牙、10600
- Hospital Virgen Del Puerto
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Cádiz
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Jerez de la Frontera、Cádiz、西班牙、11404
- Hospital de Jerez
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Islas Baleares
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Palma de Mallorca、Islas Baleares、西班牙、07198
- Hospital Son Llatzer
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Madrid
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Getafe、Madrid、西班牙、28901
- Hospital de Getafe
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Leganés、Madrid、西班牙、28911
- Hospital Severo Ochoa
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Móstoles、Madrid、西班牙、28935
- Hospital De Mostoles
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Pozuelo de Alarcón、Madrid、西班牙、28223
- Hospital Quirón
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Navarra
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Tudela、Navarra、西班牙、31500
- Hospital Reina Sofía de Tudela
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Pontevedra
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Vigo、Pontevedra、西班牙、36214
- Hospital Do Meixoeiro
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Tenerife
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La Laguna、Tenerife、西班牙、38320
- Hospital Universitario de Canarias
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Santa Cruz de Tenerife、Tenerife、西班牙、38010
- Hospital Universitario de la Candelaria
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Teruel
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Alcañiz、Teruel、西班牙、44600
- Hospital de Alcañiz
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Vizcaya
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Galdakao、Vizcaya、西班牙、48960
- Hospital de Galdakao
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Álava
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Vitoria、Álava、西班牙、01009
- Hospital de Txagorritxu
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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
女性
取样方法
非概率样本
研究人群
Female patients with disseminated HER2+ breast cancer in first line treatment
描述
Inclusion Criteria:
- Women with 18 years or over
- Patients with disseminated breast cancer histologically or cytological confirmed, who begins with Her 2+ metastatic breast cancer or develops a metastasis after or during the adjuvant therapy
- Patients treated in first line treatment in metastatic disease.
- Patients who have positive Her 2 receptor test
- Patients who have given their written informed consent
Exclusion Criteria:
- Patients who are participating in other studies
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
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
大体时间：1 day (there is no follow-up, it is a cross-sectional study)
|
General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis
|
1 day (there is no follow-up, it is a cross-sectional study)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
大体时间：one day (there is no follow-up, it is a cross-sectional study)
|
one day (there is no follow-up, it is a cross-sectional study)
|
|
|
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
大体时间：one day (there is no follow-up, it si a cross-sectional study)
|
one day (there is no follow-up, it si a cross-sectional study)
|
|
|
Adjuvant Treatment and Age
大体时间：one day (there is no follow-up, it is a cross-sectional study)
|
Adjuvant treatment and clinical profile (age) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) |
one day (there is no follow-up, it is a cross-sectional study)
|
|
Adjuvant Treatment-Physical Activity
大体时间：one day (there is no follow-up, it is a cross-sectional study)
|
Adjuvant treatment and clinical profile (Physical activity) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) |
one day (there is no follow-up, it is a cross-sectional study)
|
|
Adjuvant Treatment-Node Affectation
大体时间：one day (there is no follow-up, it is a cross-sectional study)
|
Adjuvant treatment and clinical profile (Node affectation) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) |
one day (there is no follow-up, it is a cross-sectional study)
|
|
Disseminated Breast Cancer Treatment-Age
大体时间：one day (there is no follow-up, it is a cross-sectional study)
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Analyse disseminated Breast Cancer treatment and clinical profile (age)
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one day (there is no follow-up, it is a cross-sectional study)
|
|
Disseminated Breast Cancer Treatment-physical Activity
大体时间：one day (there is no follow-up, it is a cross-sectional study)
|
Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
|
one day (there is no follow-up, it is a cross-sectional study)
|
|
Disseminated Breast Cancer Treatment-Smoking
大体时间：one day (there is no follow-up, it is a cross-sectional study)
|
Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
|
one day (there is no follow-up, it is a cross-sectional study)
|
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。
调查人员
- 首席研究员：Mª Helena López Ceballos, MD、Hospital San Pedro Alcántara
- 首席研究员：Santiago González Santiago, MD、Hospital San Pedro Alcántara
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
2011年7月1日
初级完成 (实际的)
2013年3月1日
研究完成 (实际的)
2013年3月1日
研究注册日期
首次提交
2012年7月13日
首先提交符合 QC 标准的
2012年7月19日
首次发布 (估计)
2012年7月20日
研究记录更新
最后更新发布 (估计)
2014年1月8日
上次提交的符合 QC 标准的更新
2013年11月20日
最后验证
2013年11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.