Register of breast cancer cases during pregnancy
Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy
This study collects information from women who have been diagnosed with breast cancer while pregnant to see how the disease and its treatments affect both the mothers and their babies over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Sex | Female |
| Sponsor | GBG Forschungs GmbH Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Neu-Isenburg, Hessen) |
| Trial ID | NCT00196833 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on women diagnosed with breast cancer during pregnancy, focusing on both maternal and fetal outcomes. It aims to gather information on the types of treatments administered, responses to chemotherapy, and surgical interventions, as well as the health of the mother and child five years post-therapy. The study includes both prospective and retrospective data collection, ensuring a comprehensive understanding of the implications of breast cancer during pregnancy. The data will be anonymized and stored in a database for further analysis.
Who should consider this trial
Good fit: Ideal candidates include women with histologically confirmed breast cancer diagnosed during pregnancy and women under 40 with confirmed breast cancer who are not currently pregnant.
Not a fit: Patients diagnosed with breast cancer outside of pregnancy or those over 40 years of age at diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the best treatment approaches for pregnant women with breast cancer, improving outcomes for both mothers and their children.
How similar studies have performed: While there is limited data on similar studies, the increasing incidence of breast cancer in pregnant women suggests a need for more research in this area, making this study particularly relevant.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Cohort 1: Diagnosis of breast cancer outside the period of pregnancy * Cohort 2: Age at diagnosis of breast cancer \> 40 years
Where this trial is running
Neu-Isenburg, Hessen
- German Breast Group — Neu-Isenburg, Hessen, Germany (Recruiting)
Study contacts
- Principal investigator: Sibylle Loibl, Prof. Dr. — GBG Forschungs GmbH
- Study coordinator: Sibylle Loibl, Prof. Dr.
- Email: Sibylle.Loibl@gbg.de
- Phone: +49 6102-7480-
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.