Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00007803

Trial Description

start of 1:1-Block title

Title

Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

BCP

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Women who were diagnosed with breast cancer during their pregnancy may be registered in this
trial.

Data is collected on the foetal outcome 4 weeks after delivery, maternal outcome of
pregnancy as well as the breast cancer therapy applied (treatment, response to chemotherapy,
type of surgery), diagnostic procedures applied (palpation, US, mammogram) and the outcome
of mother and child after 5 years of therapy.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Breast cancer is the most common cancer malignancy in women of childbearing age after the
age of 25 years. Since the incidence of breast cancer under the age of 40 is increasing, and
women tend to delay pregnancy into later reproductive years, the coincidence of pregnancy
and breast cancer is increasing. About 1 in 1,000 pregnancies is complicated by breast
cancer. Nevertheless, little is known about the right therapy for the mother and the unborn
child. We are therefore carrying out a trial, collecting prospective and retrospective data
about pregnant women, with histological confirmed breast cancer. Data on the biology of the
tumour and placenta tissues is also collected. The anonymous data is collected in a
database.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007803
  •   2015/02/12
  •   2005/09/12
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00196833  (ClinicalTrials.gov)
  •   GBG 29  (German Breast Group)
  •   BIG 2-03 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  • [---]*
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

[---]*

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2003/04/30
  •   500
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Women with histologically confirmed breast cancer during pregnancy.

- Informed consent for data and specimen collection.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Diagnosis of breast cancer outside the period of pregnancy.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • German Breast Group
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • University Hospital, Frankfurt
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • German Breast Group
    • Sibylle Loibl, PD.MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Sibylle Loibl, PD.MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2015/02/09
* This entry means the parameter is not applicable or has not been set.