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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01645059

Acronym

PRIMHER

Enrollment

129

Registered

2012-07-20

Start date

2011-07-31

Completion date

2013-03-31

Last updated

2014-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated HER2+ Breast Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)	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

Secondary

Measure	Time frame	Description
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy	one day (there is no follow-up, it si a cross-sectional study)	—
Adjuvant Treatment and Age	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)
Adjuvant Treatment-Physical Activity	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)
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)	—
Disseminated Breast Cancer Treatment-Age	one day (there is no follow-up, it is a cross-sectional study)	Analyse disseminated Breast Cancer treatment and clinical profile (age)
Disseminated Breast Cancer Treatment-physical Activity	one day (there is no follow-up, it is a cross-sectional study)	Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
Disseminated Breast Cancer Treatment-Smoking	one day (there is no follow-up, it is a cross-sectional study)	Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
Adjuvant Treatment-Node Affectation	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)

Countries

Spain

Participant flow

Recruitment details

First Patient included: 28th july 2011 Last Patient included: 27 th march 2013 Location: outpatient department

Participants by arm

Arm	Count
Disseminated Her 2+ Breast Cancer	129
Total	129

Baseline characteristics

Characteristic	Disseminated Her 2+ Breast Cancer
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	38 Participants
Age, Categorical Between 18 and 65 years	91 Participants
Age, Continuous	58.1 years STANDARD_DEVIATION 13.9
Region of Enrollment Spain	129 participants
Sex: Female, Male Female	129 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 129
serious Total, serious adverse events	0 / 129

Outcome results

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

Time frame: 1 day (there is no follow-up, it is a cross-sectional study)

Arm	Measure	Group	Value (NUMBER)
Disseminated Her 2+ Breast Cancer	The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)	Ductal Carcinoma	84.1 percentage of participants
Disseminated Her 2+ Breast Cancer	The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)	Positive Estrogen Receptor	57.5 percentage of participants
Disseminated Her 2+ Breast Cancer	The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)	Perfomance Status (ECOG) 0	63.5 percentage of participants
Disseminated Her 2+ Breast Cancer	The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)	Metastasic Breast Cancer	48.8 percentage of participants
Disseminated Her 2+ Breast Cancer	The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)	Histological Grade III	41.1 percentage of participants
Disseminated Her 2+ Breast Cancer	The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)	Node involvement	78.0 percentage of participants

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)