Studieoverzicht - 2003-04 Pregnancy

 
Number 2003-04 Pregnancy
Nickname Pregnancy
Status Follow up Date: 03-08-2017
Inclusion closed 03-08-2017
Other study number(s) GBG 29, BIG 2-03
Participating parties/groups GBG, BIG
Full title Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy.
Phase and type Observational
Age ≥ 18
Menopausal status Premenopausal
Indication Not applicable
Subindication Any HER2, any HR
Target sample size 1500
Actual accrual 773 (NL 119) Date: 01-03-2017
Estimated study completion date
CCMO approval Not applicable Date: Nr:
EudraCT nr. nvt
Trial Register nvt
METC approval Not applicable Date: 25-08-2005 METC: Erasmus Medisch Centrum Rotterdam Nr: MEC2005-152, statement of no objection
Amendments Yes Date: 24-02-2014
KWF-CKS approval Not applicable Date: Nr:
News item
Website http://www.bigagainstbreastcancer.org/what-we-do/clinical-trials/big-2-03-breast-cancer-pregnancy
Sponsor GBG
Principal Investigator(s) C. van Zuylen
Study manager A.E. van Leeuwen-Stok, N.H. Dijkstra
Central datamanagement and randomization BOOG Study Center
Postbus 9236
1006 AE Amsterdam
tel 088-2346730
fax 088-2346739
email info@boogstudycenter.nl
Monitoring Not applicable
Local datamanagement
Funding
Extra

Design:

Registration study

Objectives:
Endpoints:

Primary endpoint:
Outcome child 4 weeks after partus

Secondary endpoints:
Maternal outcome of pregnancy; Stage of and biological characteristics of breast cancer; Breast cancer therapy (treatment, response to chemotherapy, type of surgery);Sensitivity and specifity of diagnostic procedures (palpation, US, mammogram);Outcome of the newborn after 5 years of therapy; Outcome of breast cancer 5 years after diagnosis

Main eligibility criteria:

Breast cancer during pregnancy (histologically confirmed) Informed consent when prospective registration

Documents (public):
Documents (protected):
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