Trial Outcomes & Findings for 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 (NCT NCT01645059)
NCT ID: NCT01645059
Last Updated: 2014-01-08
Results Overview
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
COMPLETED
129 participants
1 day (there is no follow-up, it is a cross-sectional study)
2014-01-08
Participant Flow
First Patient included: 28th july 2011 Last Patient included: 27 th march 2013 Location: outpatient department
Participant milestones
| Measure |
Disseminated Her 2+ Breast Cancer
|
|---|---|
|
Overall Study
STARTED
|
129
|
|
Overall Study
COMPLETED
|
129
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Disseminated Her 2+ Breast Cancer
n=129 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
91 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
129 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=129 Participants
|
No Trastuzumab Adjuvant Treatment
|
|---|---|---|
|
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Perfomance Status (ECOG) 0
|
63.5 percentage of participants
Interval 54.4 to 71.8
|
—
|
|
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Metastasic Breast Cancer
|
48.8 percentage of participants
Interval 40.0 to 57.7
|
—
|
|
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Ductal Carcinoma
|
84.1 percentage of participants
Interval 76.3 to 89.8
|
—
|
|
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Histological Grade III
|
41.1 percentage of participants
Interval 32.6 to 50.1
|
—
|
|
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Node involvement
|
78.0 percentage of participants
Interval 69.3 to 84.9
|
—
|
|
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Positive Estrogen Receptor
|
57.5 percentage of participants
Interval 48.4 to 66.1
|
—
|
SECONDARY outcome
Timeframe: one day (there is no follow-up, it is a cross-sectional study)Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=66 Participants
|
No Trastuzumab Adjuvant Treatment
|
|---|---|---|
|
Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
Adjuvant treatment (Chemotherapy with TAC)
|
22.0 percentage of participants
Interval 12.0 to 36.3
|
—
|
|
Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
Adjuvant treatment (Hormonal therapy tamoxifen)
|
41.7 percentage of participants
Interval 26.0 to 59.2
|
—
|
SECONDARY outcome
Timeframe: one day (there is no follow-up, it si a cross-sectional study)Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=129 Participants
|
No Trastuzumab Adjuvant Treatment
|
|---|---|---|
|
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
First line-Chemotherapy
|
86.8 percentage of participants
|
—
|
|
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Chemotherapy with Taxanes
|
37.5 percentage of participants
|
—
|
|
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Chemotherapy with Taxanes-Anthraciclines
|
20.5 percentage of participants
|
—
|
|
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Chemotherapy Vinorelbine
|
17.0 percentage of participants
|
—
|
|
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Hormonotherapy+ trastuzumab
|
8.5 percentage of participants
|
—
|
|
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Chemotherapy+ trastuzumab
|
86.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=33 Participants
|
No Trastuzumab Adjuvant Treatment
n=33 Participants
|
|---|---|---|
|
Adjuvant Treatment and Age
|
55.3 years
Standard Deviation 10.4
|
61.8 years
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=32 Participants
|
No Trastuzumab Adjuvant Treatment
n=28 Participants
|
|---|---|---|
|
Adjuvant Treatment-Physical Activity
|
56.3 percentage of patients physical activity
|
17.9 percentage of patients physical activity
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=27 Participants
|
No Trastuzumab Adjuvant Treatment
n=18 Participants
|
|---|---|---|
|
Adjuvant Treatment-Node Affectation
|
84.4 percentage of patients node affectation
|
54.5 percentage of patients node affectation
|
SECONDARY outcome
Timeframe: one day (there is no follow-up, it is a cross-sectional study)Analyse disseminated Breast Cancer treatment and clinical profile (age)
Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=79 Participants
|
No Trastuzumab Adjuvant Treatment
n=50 Participants
|
|---|---|---|
|
Disseminated Breast Cancer Treatment-Age
|
56.1 years
Standard Deviation 13.5
|
61.3 years
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: one day (there is no follow-up, it is a cross-sectional study)Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=75 Participants
|
No Trastuzumab Adjuvant Treatment
n=44 Participants
|
|---|---|---|
|
Disseminated Breast Cancer Treatment-physical Activity
|
24 percentage of patients physical activity
|
43.2 percentage of patients physical activity
|
SECONDARY outcome
Timeframe: one day (there is no follow-up, it is a cross-sectional study)Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
Outcome measures
| Measure |
Disseminated Her 2+ Breast Cancer
n=76 Participants
|
No Trastuzumab Adjuvant Treatment
n=47 Participants
|
|---|---|---|
|
Disseminated Breast Cancer Treatment-Smoking
|
25 percentage of smoking participants
|
6.4 percentage of smoking participants
|
Adverse Events
Disseminated Her 2+ Breast Cancer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60