An observational study in Disseminated HER2+ Breast Cancer, sponsored by Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica. Completed at 39 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-08.
Sponsored by Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 129 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Female patients with disseminated HER2+ breast cancer in first line treatment
Exclusion Criteria:
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
Time frame: 1 day (there is no follow-up, it is a cross-sectional study)
Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: one day (there is no follow-up, it is a cross-sectional study)
First Patient included: 28th july 2011 Last Patient included: 27 th march 2013 Location: outpatient department
| Milestone | Disseminated Her 2+ Breast Cancer |
|---|---|
| Started | 129 |
| Completed | 129 |
| Not completed | 0 |
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
| percentage of participants | Disseminated Her 2+ Breast Cancer |
|---|---|
| Perfomance Status (ECOG) 0 | 63.5 (54.4 to 71.8) |
| Metastasic Breast Cancer | 48.8 (40.0 to 57.7) |
| Ductal Carcinoma | 84.1 (76.3 to 89.8) |
| Histological Grade III | 41.1 (32.6 to 50.1) |
| Node involvement | 78.0 (69.3 to 84.9) |
| Positive Estrogen Receptor | 57.5 (48.4 to 66.1) |
| percentage of participants | Disseminated Her 2+ Breast Cancer |
|---|---|
| Adjuvant treatment (Chemotherapy with TAC) | 22.0 (12 to 36.3) |
| Adjuvant treatment (Hormonal therapy tamoxifen) | 41.7 (26.0 to 59.2) |
| percentage of participants | Disseminated HER 2 + Breast Cancer |
|---|---|
| First line-Chemotherapy | 86.8 |
| Chemotherapy with Taxanes | 37.5 |
| Chemotherapy with Taxanes-Anthraciclines | 20.5 |
| Chemotherapy Vinorelbine | 17.0 |
| Hormonotherapy+ trastuzumab | 8.5 |
| Chemotherapy+ trastuzumab | 86.8 |
Adjuvant treatment and clinical profile (age) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
| years | Trastuzumab Adjuvant Treatment | No Trastuzumab Adjuvant Treatment |
|---|---|---|
| Adjuvant Treatment and Age | 55.3 ± 10.4 | 61.8 ± 13.4 |
Adjuvant treatment and clinical profile (Physical activity) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
| percentage of patients physical activity | Trastuzumab Adjuvant Treatment | No Trastuzumab Adjuvant Treatment |
|---|---|---|
| Adjuvant Treatment-Physical Activity | 56.3 | 17.9 |
Adjuvant treatment and clinical profile (Node affectation) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
| percentage of patients node affectation | Trastuzumab Adjuvant Treatment | No Trastuzumab Adjuvant Treatment |
|---|---|---|
| Adjuvant Treatment-Node Affectation | 84.4 | 54.5 |
Analyse disseminated Breast Cancer treatment and clinical profile (age)
| years | Taxanes First Line Treatment | No Taxanes First Line Treatment |
|---|---|---|
| Disseminated Breast Cancer Treatment-Age | 56.1 ± 13.5 | 61.3 ± 14.1 |
Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
| percentage of patients physical activity | Taxanes First Line Treatment | No Taxanes First Line Treatment |
|---|---|---|
| Disseminated Breast Cancer Treatment-physical Activity | 24 | 43.2 |
Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
| percentage of smoking participants | Taxanes First Line Treatment | No Taxanes First Line Treatment |
|---|---|---|
| Disseminated Breast Cancer Treatment-Smoking | 25 | 6.4 |
Collected over 1 day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Disseminated Her 2+ Breast Cancer | — | 0/129 (0%) | 0/129 (0%) |
| Age, Categorical(Participants) | Disseminated Her 2+ Breast Cancer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 91 |
| >=65 years | 38 |
| Age, Continuous(years) | Disseminated Her 2+ Breast Cancer |
|---|---|
| Mean | 58.1 ± 13.9 |
| Sex: Female, Male(Participants) | Disseminated Her 2+ Breast Cancer |
|---|---|
| Female | 129 |
| Male | 0 |
| Region of Enrollment(participants) | Disseminated Her 2+ Breast Cancer |
|---|---|
| Spain | 129 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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