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English Summary - Brustkrebs in der Schwangerschaft

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

Current Status: Open to accrual

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. We therefore want to initiate a trial collecting prospectively as well as retrospectively data for the diagnostic, treatment, maternal and foetal outcome during pregnancy.

Trial design

Long time retrospective/prospective registry for patients with B.C.P.

Treatment

A flow sheet of diagnosis and treatment, which is not obligatory, is provided in order to guide the investigator in the treatment of patients with B.C. during pregnancy.

Patient population, Inclusion criteria

1. Patients with histological confirmed breast cancer who are pregnant
2. Informed consent for data collection
3. Patient is suitable for surgery and chemotherapy
4. Pregnancy without complication

Primary endpoint

Newborn assessment four weeks after delivery.

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 year of therapy
* Outcome of breast cancer 5 years after diagnosis

Addenda

Protocol version III incl Amd. 1, 2 and 3; 01.01.2007 Tissue collection of the breast cancer and placenta

Available documents

The documents of this study are available for download and printout as pdf.

• Protocol version III (incl. Amendment 1-3) 1.1.07 Protocol includes flow sheets for therapy, patient information and informed consent
• case report forms (CRFs)
• Patient informed consent

Reference

Loibl S., von Minckwitz G., Gwyn K., Ellis P., Blohmer JU., Schlegelberger B., Keller M., Harder S., Theriault RL, Crivellari D., Klingebiel T., Louwen F., Kaufmann M. Breast Carcinoma During Pregnancy. Cancer 2006; 106: 237-246.

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• Study Group: German Breast Group (GBG), Breast International Group (BIG)
• Sponsor: GBG Forschungs GmbH
• Cooperation with: BANSS-Foundation, Biedenkopf; Universitätsfrauenklinik Frankfurt
• Study Chair: Prof. Dr. Sibylle Loibl
• Clinical Project Management: GBG Forschungs GmbH
• Data Management / Biometry: Dr. Valentina Nekljudova
• Enrollment period: April 2003 - ongoing

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