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Pregnancy

  • Follow up

BOOG 2003-04

General Information

BOOG number

BOOG 2003-04

Nickname

Pregnancy

Status

  • Follow up
Date: 03/08/2017

Inclusion closed

03/08/2017

Participating parties / group

GBG, BIG

Other study number

GBG 29, BIG 2-03

Full title

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

Indication

  • Not applicable

Subindication

Any HER2, any HR

Target sample size

1500

Actual accrual

773 (NL 119)
Date: 01/03/2017

Contact

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
tel 088-2346730
email info@boogstudycenter.nl

Monitoring

Not applicable

Other

http://www.bigagainstbreastcancer.org/what-we-do/clinical-trials/big-2-03-breast-cancer-pregnancy

Design

Registration study

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

Eligibility Criteria

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

Regulatory Information

CCMO approval

Yes

EC approval

Not applicable
Date: 25/08/2005
Nr:MEC2005-152, statement of no objection

EC

Erasmus Medisch Centrum Rotterdam
Amendments:
Yes
Date Last Amendment: 24/02/2014

EudraCT number

nvt

Trial Register

nvt

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