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Breast Cancer in Pregnancy Register Study (BCP)

This study is currently recruiting participants.
Verified August 2017 by German Breast Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196833
First Posted: September 20, 2005
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University Hospital, Frankfurt
Information provided by (Responsible Party):
German Breast Group
September 12, 2005
September 20, 2005
August 2, 2017
April 2003
April 2019   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00196833 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Breast Cancer in Pregnancy Register Study
Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy

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.

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.
Observational
Observational Model: Other
Time Perspective: Other
Not Provided
Retention:   Samples With DNA
Description:
Tumour and placenta specimens are collected
Non-Probability Sample
Women with histologically confirmed breast cancer during pregnancy.
Breast Cancer
Not Provided
Not Provided
Loibl S, Han SN, von Minckwitz G, Bontenbal M, Ring A, Giermek J, Fehm T, Van Calsteren K, Linn SC, Schlehe B, Gziri MM, Westenend PJ, Müller V, Heyns L, Rack B, Van Calster B, Harbeck N, Lenhard M, Halaska MJ, Kaufmann M, Nekljudova V, Amant F. Treatment of breast cancer during pregnancy: an observational study. Lancet Oncol. 2012 Sep;13(9):887-96. doi: 10.1016/S1470-2045(12)70261-9. Epub 2012 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
April 2019
April 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with histologically confirmed breast cancer during pregnancy.
  • Informed consent for data and specimen collection.

Exclusion Criteria:

  • Diagnosis of breast cancer outside the period of pregnancy.
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact: Sibylle Loibl, PD.MD +49 6102-7480- ext 426 Sibylle.Loibl@gbg.de
Germany
 
 
NCT00196833
GBG 29
BIG 2-03 ( Other Identifier: BIG )
No
Not Provided
Not Provided
German Breast Group
German Breast Group
University Hospital, Frankfurt
Principal Investigator: Sibylle Loibl, PD.MD German Breast Group
German Breast Group
August 2017