BRCA-P

An observational study on the course of pregnancies in women with hereditary breast cancer (BRCA mutation). Participants with hereditary breast cancer who have not been pregnant are also being sought as controls.

Gender
Women
Age
18–40 years
Trial type
Observational
Line of therapy
all
Phase

What is this trial about?

Specific genetic changes, such as the BRCA1/2 mutation, are associated with an increased risk of breast cancer. Many women affected develop the disease at a younger age. Pregnancy leads to numerous hormonal changes; however, specific effects on the course of breast cancer have not yet been conclusively identified. The aim of this study is to investigate the effects of pregnancy on the course of the disease in cases of known hereditary breast cancer. Women between the ages of 18 and 40 with breast cancer caused by a BRCA-1/2 mutation, with or without a subsequent pregnancy, are eligible to participate in this study. The study is purely observational; no new medications or therapies are being tested.

Detailed description

Breast cancer (mammary carcinoma) is a malignant disease of the breast tissue characterized by the uncontrolled proliferation of breast cells. A major cause of breast cancer, particularly at a young age (usually before age 40), is hereditary genetic changes such as the BRCA1/2 mutation. If this genetic mutation is present, the risk of developing breast cancer or ovarian cancer is significantly increased. Fortunately, successful treatment is now possible even for these patients, allowing them to become pregnant after treatment. Hormonal changes during pregnancy could potentially affect the known cancer—even if treatment has ended—for example, with regard to the risk of a relapse (recurrence).

The aim of this observational study is to investigate the effects of pregnancy on a known hereditary form of breast cancer. To this end, the course of the pregnancies and any complications experienced by the patients are being retrospectively documented. In addition, the patients’ disease progression is monitored over a ten-year period. The study examines the extent to which disease-related events might be associated with pregnancy. To this end, data will be compared between two different groups: Group 1 comprises women who had at least one pregnancy following their initial diagnosis of breast cancer, while Group 2 comprises women who did not have a pregnancy following their initial diagnosis. The study is strictly observational; participation does not involve any additional treatment.

Patients between the ages of 18 and 40 with hereditary breast cancer (BRCA gene) with or without a subsequent pregnancy are eligible to participate in this study. The initial diagnosis must have occurred between January 2000 and December 2012.

Facts

  1. What condition: hereditary breast cancer (breast carcinoma)
  2. Cancer characteristics: BRCA gene mutation, diagnosis prior to pregnancy
  3. What the study investigates: effects of pregnancies on the course of breast carcinoma
  4. Study objective: To identify possible associations between pregnancy and the disease
  5. Study duration: Approximately 10 years
  6. Study characteristics: Retrospective, observational, two groups (with and without pregnancy)

Trial sites

2 trial sites in Germany are listed.

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

    Status unknown
  • Leitung, Brustzentrum der Universität München (LMU)

    München

    Status unknown

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT03673306) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.