Breast Cancer in Pregnancy Register Study

Breast Cancer Clinical Trial

— BCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00196833
• Other study ID #: GBG 29
• Secondary ID: BIG 2-03
• Status: Recruiting
• Start date: April 2003
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: German Breast Group
• Contact: Sibylle Loibl, Prof. Dr.
• Phone: +49 6102-7480-
• Email: Sibylle.Loibl[@]gbg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Germany	German Breast Group	Neu-Isenburg	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
German Breast Group	Goethe University

Country where clinical trial is conducted

Germany, 

External Links

•   Click here for more information about this study: Breast Cancer in Pregnancy