Metastatic Breast Cancer in Austria

NCT03870620

Last updated date
Study Location
BHS Linz
Linz, Oberösterreich, 4020, Austria
Contact
+43 57255

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Breast Carcinoma, Breast Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histological evidence of breast cancer

- Histological and/or radiological evidence of metastases

- Metastasis within 10 years of registry initiation

- Signed informed consent (if a patient has already died at the time of entry, the entry can be made without a declaration of consent)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Due to the non-interventional design of the registry there are no specific exclusion
criteria.

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Breast Cancer, Breast Carcinoma, Breast TumorMetastatic Breast Cancer in Austria
NCT03870620
  1. Linz, Oberösterreich
  2. Linz, Oberösterreich
  3. Steyr, Oberösterreich
  4. Wels, Oberösterreich
  5. Graz, Steiermark
  6. Innsbruck, Tirol
  7. Kufstein, Tirol
  8. Feldkirch, Vorarlberg
  9. Salzburg,
  10. Wien,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Metastatic Breast Cancer in Austria
Official Title Metastatic Breast Cancer in Austria
Brief Summary

Breast cancer is the most common cancer among women worldwide. In Austria, this diagnosis is made more than 5000 times a year (STATISTICS AUSTRIA, Austrian Cancer Registry, as of 24.09.2012). Of these, already 5% to 10% have distant metastases at the time of initial diagnosis, and up to 30% of the node-negative tumours and up to 70% of the node-positive tumours metastasise at a later date. Metastatic breast cancer has not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardised documentation of this disease. The aim of the registry is to answer both epidemiological and therapy-specific questions.

This registry is a prospective and retrospective, multicentre collection of data on patients with metastatic breast cancer in Austria. All tumour characteristics, medical histories and also treatment sequences are documented in anonymised form.

Detailed Description

The present AGMT registry will provide accurate documentation of initial disease progression and initial tumour characteristics in patients with metastatic breast cancer in Austria. The data collected will include: median age at metastasis, median disease-free survival (DFS) between initial diagnosis or first date of absence of disease and occurrence of metastasis, histological subtype of the primary tumour, initial TNM stage, grade and receptor status of the primary tumour, type and form of adjuvant therapy, pattern of metastasis and metastasis site. Characteristics that have a negative prognostic value are expected to be overrepresented in the metastatic patient group.

Also, this AGMT registry is intended to assess the distribution pattern of these metastatic stage subtypes in Austria. Additionally, their influence on treatment strategy and outcome is to be studied. Furthermore, the frequency and tumour characteristics of breast cancer in male patients will be assessed and the influence of gender on treatment strategies identified.

The AGMT breast cancer registry will conduct an exact analysis of survival data, thereby enabling accurate calculations of average survival duration in patients with metastatic breast cancer in Austria. Further parameters that reflect the quality or course of oncological treatment are the survival rates from the time of metastasis development at 1, 2 and 5 years after diagnosis.

This AGMT registry is intended to investigate the response to various therapies in a real life population in relation to previous treatments, concomitant diseases and breast cancer subtype. The aim is to assess which therapies are used at which time point and on which disease subtype they depend.

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This registry is a prospective and retrospective, multicentre collection of data on patients with metastatic breast cancer in Austria.
Condition
  • Breast Cancer
  • Breast Carcinoma
  • Breast Tumor
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 8, 2019)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Histological evidence of breast cancer
  • Histological and/or radiological evidence of metastases
  • Metastasis within 10 years of registry initiation
  • Signed informed consent (if a patient has already died at the time of entry, the entry can be made without a declaration of consent)

Exclusion Criteria:

  • Due to the non-interventional design of the registry there are no specific exclusion criteria.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Richard Greil, MD+43 57255 ext 25801[email protected]
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT03870620
Other Study ID Numbers AGMT_MBC-Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Sponsor Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
  • Hoffmann-La Roche
  • Pfizer
Investigators
Principal Investigator:Richard Greil, MDIIIrd Medical Department, Private Medical University Hospital Salzburg
PRS Account Arbeitsgemeinschaft medikamentoese Tumortherapie
Verification Date July 2020