N/A
N=129
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
Disseminated HER2+ Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01645059 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics) — 63.5; 48.8; 84.1; 41.1 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics) |
63.5; 48.8; 84.1; 41.1; 78.0; 57.5 | — |
| SECONDARY Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy |
22.0; 41.7 | — |
| SECONDARY The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy |
86.8; 37.5; 20.5; 17.0; 8.5; 86.8 | — |
| SECONDARY Adjuvant Treatment and Age |
55.3; 61.8 | — |
| SECONDARY Adjuvant Treatment-Physical Activity |
56.3; 17.9 | — |
| SECONDARY Adjuvant Treatment-Node Affectation |
84.4; 54.5 | — |
| SECONDARY Disseminated Breast Cancer Treatment-Age |
56.1; 61.3 | — |
| SECONDARY Disseminated Breast Cancer Treatment-physical Activity |
24; 43.2 | — |
| SECONDARY Disseminated Breast Cancer Treatment-Smoking |
25; 6.4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01645059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.