Breast Cancer in Pregnancy Register Study
BCP
Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy
2 other identifiers
observational
1,100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedApril 17, 2024
April 1, 2024
22 years
September 12, 2005
April 16, 2024
Conditions
Keywords
Eligibility Criteria
Cohort 1: Women with histologically confirmed breast cancer during pregnancy Cohort 2: Young women (age ≤ 40 years) with histologically confirmed breast cancer (outside of pregnancy or recently pregnant)
You may qualify if:
- Cohort 1: Women with histologically confirmed breast cancer during pregnancy
- Cohort 2: Patients ≤ 40 years with histological confirmed breast cancer who are not pregnant (patients who have been pregnant recently can also be collected into this cohort)
- Informed consent for data collection (for prospective participants) and biomaterial collection. For retrospective participants an informed consent is not required as long as the data are anonymously captured
You may not qualify if:
- Cohort 1: Diagnosis of breast cancer outside the period of pregnancy
- Cohort 2: Age at diagnosis of breast cancer \> 40 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GBG Forschungs GmbHlead
- Goethe Universitycollaborator
Study Sites (1)
German Breast Group
Neu-Isenburg, Hesse, 63263, Germany
Related Publications (1)
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, Muller 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.
PMID: 22902483DERIVED
Related Links
Biospecimen
Tumour and placenta specimens are collected
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sibylle Loibl, Prof. Dr.
GBG Forschungs GmbH
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
April 1, 2003
Primary Completion
April 1, 2025
Study Completion
April 1, 2026
Last Updated
April 17, 2024
Record last verified: 2024-04