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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.
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| Measure | Description | Time Frame |
|---|---|---|
| The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients with disseminated HER2+ breast cancer in first line treatment
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| Name | Affiliation | Role |
|---|---|---|
| Mª Helena López Ceballos, MD | Hospital San Pedro Alcántara | Principal Investigator |
| Santiago González Santiago, MD | Hospital San Pedro Alcántara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Denia | Denia | Alicante | 03700 | Spain | ||
| Hospital General de Elda |
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First Patient included: 28th july 2011 Last Patient included: 27 th march 2013 Location: outpatient department
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| ID | Title | Description |
|---|---|---|
| FG000 | Disseminated Her 2+ Breast Cancer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| one day (there is no follow-up, it si a cross-sectional study) |
| Adjuvant Treatment and Age | 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 | 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 | 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 | Analyse disseminated Breast Cancer treatment and clinical profile (age) | one day (there is no follow-up, it is a cross-sectional study) |
| Disseminated Breast Cancer Treatment-physical Activity | 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 | Analyse disseminated Breast Cancer treatment and clinical profile (Smoking) | one day (there is no follow-up, it is a cross-sectional study) |
| Elda |
| Alicante |
| 03600 |
| Spain |
| Hospital de Torrecárdenas | Almería | Almería | 04009 | Spain |
| Hospital Infanta Cristina de Badajoz | Badajoz | Badajoz | 06008 | Spain |
| Hospital don Benito | Don Benito | Badajoz | 06400 | Spain |
| Hospital de Llerena | Llerena | Badajoz | 06900 | Spain |
| Hospital de Mérida | Mérida | Badajoz | 06800 | Spain |
| Hospital Son Llàtzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| ICO Badalona | Badalona | Barcelona | 08916 | Spain |
| Clínica Corachan | Barcelona | Barcelona | 08017 | Spain |
| Hospital General de l'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08906 | Spain |
| Complejo Hospitalario Ciudad Real | Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital San Pedro Alcántara | Cáceres | Cáceres | 10003 | Spain |
| Hospital Virgen del Puerto | Plasencia | Cáceres | 10600 | Spain |
| Hospital de Jerez | Jerez de la Frontera | Cádiz | 11404 | Spain |
| Hospital de León | León | León | 24008 | Spain |
| Hospital Universitario Arnau de Vilanova | Lleida | Lleida | 25198 | Spain |
| Hospital Lucus Augusti | Lugo | Lugo | 27003 | Spain |
| Hospital de Getafe | Getafe | Madrid | 28901 | Spain |
| Hospital Severo Ochoa | Leganés | Madrid | 28911 | Spain |
| Hospital La Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital de Móstoles | Móstoles | Madrid | 28935 | Spain |
| Hospital Quirón | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Morales Messeguer | Murcia | Murcia | 30008 | Spain |
| Hospital Reina Sofía de Tudela | Tudela | Navarre | 31500 | Spain |
| Hospital do Meixoeiro | Vigo | Pontevedra | 36214 | Spain |
| Hospital de Cabueñes | Gijón | Principality of Asturias | 33203 | Spain |
| Hospital General de Segovia | Segovia | Segovia | 40002 | Spain |
| Hospital Virgen de la Macarena | Seville | Sevilla | 41009 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital Universitario de la Candelaria | Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Hospital de Alcañiz | Alcañiz | Teruel | 44600 | Spain |
| Hospital General Universitario de Valencia | Valencia | Valencia | 46014 | Spain |
| Hospital Dr.Peset | Valencia | Valencia | 46017 | Spain |
| Hospital Clínico de Valladolid | Valladolid | Valladolid | 47005 | Spain |
| Hospital Universitario Rio Hortega | Valladolid | Valladolid | 47012 | Spain |
| Hospital de Galdakao | Galdakao | Vizcaya | 48960 | Spain |
| Hospital de Zamora | Zamora | Zamora | 49021 | Spain |
| Hospital de Txagorritxu | Vitoria-Gasteiz | Álava | 01009 | Spain |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Disseminated Her 2+ Breast Cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics) | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | 1 day (there is no follow-up, it is a cross-sectional study) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy | Posted | Number | 95% Confidence Interval | percentage of participants | one day (there is no follow-up, it is a cross-sectional study) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy | Posted | Number | percentage of participants | one day (there is no follow-up, it si a cross-sectional study) |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Adjuvant Treatment and Age | Adjuvant treatment and clinical profile (age) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) | Posted | Mean | Standard Deviation | years | one day (there is no follow-up, it is a cross-sectional study) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Adjuvant Treatment-Physical Activity | Adjuvant treatment and clinical profile (Physical activity) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) | Posted | Number | percentage of patients physical activity | one day (there is no follow-up, it is a cross-sectional study) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Adjuvant Treatment-Node Affectation | Adjuvant treatment and clinical profile (Node affectation) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) | Posted | Number | percentage of patients node affectation | one day (there is no follow-up, it is a cross-sectional study) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Disseminated Breast Cancer Treatment-Age | Analyse disseminated Breast Cancer treatment and clinical profile (age) | Posted | Mean | Standard Deviation | years | one day (there is no follow-up, it is a cross-sectional study) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disseminated Breast Cancer Treatment-physical Activity | Analyse disseminated Breast Cancer treatment and clinical profile (physical activity) | Posted | Number | percentage of patients physical activity | one day (there is no follow-up, it is a cross-sectional study) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Disseminated Breast Cancer Treatment-Smoking | Analyse disseminated Breast Cancer treatment and clinical profile (Smoking) | Posted | Number | percentage of smoking participants | one day (there is no follow-up, it is a cross-sectional study) |
|
|
1 day
Is a cross-sectional study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Disseminated Her 2+ Breast Cancer | 0 | 129 | 0 | 129 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Santiago González Santiago | Hospital San Pedro Alcántara | santidatvs@hotmail.com |
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| Histological Grade III |
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| Node involvement |
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| Positive Estrogen Receptor |
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| Adjuvant treatment (Chemotherapy with TAC) |
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| Adjuvant treatment (Hormonal therapy tamoxifen) |
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| Chemotherapy with Taxanes |
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| Chemotherapy with Taxanes-Anthraciclines |
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| Chemotherapy Vinorelbine |
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| Hormonotherapy+ trastuzumab |
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| Chemotherapy+ trastuzumab |
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