Pregnancy (GBG 29)

Breast cancer is the most common cancer malignancy in women after the age of 25 years.

The age of first-time mothers is steadily increasing and is now at the age of 30 years. The incidence of breast cancer, especially in premenopausal patients, is also increasing, which is why the incidence of breast cancer during pregnancy is also rising.

As very little data is available on this patient group, the study aims to collect data on breast cancer during pregnancy prospectively and retrospectively. First and foremost, the toxicity of the therapies for mother and child in the treatment of breast cancer occurring during pregnancy is to be investigated. Guidelines for therapy will be offered and their acceptance will be investigated.

Further target criteria are the recording of the therapies, the diagnostics carried out, the late effects of the therapy on the child and the maternal outcome as well as the course of the pregnancy.

In addition, we will include a control group of non-pregnant young patients (<40 years) in the registry study. This is important in order to compare the data and results of pregnant breast cancer patients - who were treated during pregnancy - with those of non-pregnant very young breast cancer patients.

Cooperation:

The study is to be initiated within the framework of the GBG. However, in cooperation with the Breast International Group (BIG 2-03 study), other clinics are to be included in this survey, as the aim is to achieve the widest possible coverage.
Supported by the non-profit BANSS Foundation, Biedenkopf.

Status: The study is open to recruitment.

Amendments:

• BCP English Protocol 1-14 Amendment 4

The protocol includes the treatment guidelines as well as the patient information and consent form in English. Further documents can be found in the "Documents" section.

Recruitment (01.01.2023) n=3437

Prospective and Retrospective Registry Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy compared to young non-pregnant women (<40 years) as comparitive cohort
Primary endpoint:

• Foetal outcome 4 weeks after delivery

Secondary endpoint:

• Maternal outcome of pregnancy
• Stage of and biological characteristics of breast cancer
• Breast cancer therapy (treatment, response to chemotherapy in the neoadjuvant setting, type of surgery)
• Sensitivity and specifity of diagnostic procedures (palpation, US, mammogramme, MRI)
• Outcome of the newborn after therapy
• Outcome of breast cancer after diagnosis
• Rate of pregnancies after breast cancer
• Biology of the tumour of pregnant breast cancer patients measured compared to young non-pregnant women
• All parameters will be compared to young non-pregnant women

Inclusion Criteria

• Patients with histological confirmed breast cancer who are pregnant or
• Patients < 40 years with histological confirmed breast cancer who are not pregnant
• Informed consent for data collection (for prospective participants)
• Karnofsky-Index >80%
• Patient suitable for surgery and/or chemotherapy
• No pathologies of the course of pregnancy