Pregnancy (GBG 29)

Breast cancer is the most common form of cancer in women over the age of 25.
The average age at which women give birth to their first child is currently around 30 and is constantly rising. The incidence of breast cancer, above all in premenopausal patients, is also on the increase, with the result that there is a corresponding increase in the incidence of breast cancer during pregnancy.
As there is only very little data available on this patient group, the purpose of this trial is to collect data on breast cancer in pregnancy both prospectively and retrospectively.

The primary aim is to examine the toxicity for the mother and child of treatment administered for breast cancer which occurs during pregnancy.
Therapy guidelines will be proposed and their level of acceptance assessed.
Further objectives are to record therapy approaches, diagnostic methods, the long-term effects of therapy on the child, the outcome for the mother and the progression of the pregnancy.

In addition, a control group consisting of non-pregnant young patients (aged <40) will be recruited to the register trial. This is important in order to compare the data and outcomes of pregnant breast cancer patients treated during pregnancy with those of non-pregnant breast cancer patients of a very young age.

Cooperation:
The trial is to be launched by the GBG. However, in cooperation with the Breast International Group (Trial BIG 2-03), further clinics are to be included in the trial in order to achieve the best possible geographic coverage.

Sponsored by the charitable foundation BANSS-Stiftung, Biedenkopf

Status: This trial is currently still recruiting.

The average age at which women give birth to their first child is currently around 30 and is constantly rising. The incidence of breast cancer, above all in premenopausal patients, is also on the increase, with the result that there is a corresponding increase in the incidence of breast cancer during pregnancy.
As there is only very little data available on this patient group, the purpose of this trial is to collect data on breast cancer in pregnancy both prospectively and retrospectively.

The primary aim is to examine the toxicity for the mother and child of treatment administered for breast cancer which occurs during pregnancy.
Therapy guidelines will be proposed and their level of acceptance assessed.
Further objectives are to record therapy approaches, diagnostic methods, the long-term effects of therapy on the child, the outcome for the mother and the progression of the pregnancy.

In addition, a control group consisting of non-pregnant young patients (aged <40) will be recruited to the register trial. This is important in order to compare the data and outcomes of pregnant breast cancer patients treated during pregnancy with those of non-pregnant breast cancer patients of a very young age.

Prospective and retrospective register trial conducted by the German Breast Group (GBG) for the diagnosis and treatment of breast cancer in pregnancy, with young, non-pregnant patients (<40) as a comparison cohort.

Primary endpoint:

• Foetal outcome 4 weeks after childbirth

Secondary endpoints:

• Mother’s outcome with respect to the pregnancy;
• Stage and biological characteristics of the breast cancer;
• Breast cancer therapy (drugs, response to CHT, type of surgery);
• Sensitivity and specificity of diagnosis, clinical examination, ultrasound scan, mammogram, MRT;
• Outcome of therapy for the newborn child;
• Breast cancer outcome following therapy;
• Number of pregnancies following breast cancer;
• Tumour biology of pregnant patients compared with young, non-pregnant patients;
• All parameters are to be compared with young, non-pregnant patients.
  

Inclusion criteria

• Patient with histologically confirmed breast cancer in pregnancy; or
• Non-pregnant patient aged < 40 with histologically confirmed breast cancer;
• Written consent to data collection in the case of prospective patients;
• Karnofsky Index > 80%;
• Patient suitable for surgery and/or chemotherapy;
• No pathologies in pregnancy.

bcpgbgd
Fax: +4961027480440

Project management
see LKP

Project Assistents
Petra Feer
Tel.: +4961027480482
Fax: +4961027480440
ptrfrgbgd

Leiter der klinischen Prüfung (LKP)
Prof. Dr. med. S. Loibl
Tel.: +49610274800
Fax: +4961027480440
sbylllblgbgd

Subboard Adjuvant
B. Conrad, Elisabeth Krankenhaus, Kassel
C. Denkert, Charité, Berlin
H. Eidtmann, Universitätsklinikum, Kiel
W. Eiermann, Frauenklinik vom Roten Kreuz, München
N. Harbeck, Klinikum rechts der Isar, München
J. Huober, Universitätsklinikum, Tübingen
C. Jackisch, Offenbach
S. Loibl, Universitätsklinikum, Frankfurt
H.J. Lück, Medizinische Hochschule, Hannover
V. Möbus, Städt. Kliniken, Frankfurt-Höchst
T. Reimer, Universitätsklinikum, Rostock
G. von Minckwitz, GBG, Neu-Isenburg