BCPRecruiting

An observational study on the course of breast cancer that occurs during pregnancy. For comparison, young women (under 40) who are not pregnant may also participate.

Gender
Women
Age
18 years and older
Trial type
Observational
Line of therapy
all
Phase

What is this trial about?

The current body of evidence regarding the treatment of breast cancer (mammary carcinoma) that occurs during pregnancy is limited. The goal of the BCP study is to collect data on diagnosis, treatment, pregnancy outcomes, and disease progression, and to compare these findings with those of young patients with breast cancer who are not pregnant. Patients with a first diagnosis of breast cancer during pregnancy (no age restriction) or outside of pregnancy (age ≤ 40 years) are eligible to participate in this study. The study is purely observational; no new medications or therapies are being investigated.

Detailed description

Breast cancer (mammary carcinoma) is a malignant disease of the breast tissue characterized by the uncontrolled proliferation of breast cells. In recent years, the number of new cases among women under the age of 40 has risen, and there has been an observed increase in the number of pregnancies among women of advanced childbearing age. As a result, breast cancer is occurring more frequently during pregnancy. At present, however, the available data regarding the treatment of pregnant women and their unborn children is very limited.

The aim of this observational study is to collect and analyze data regarding the diagnosis, treatment, course of pregnancy, and disease progression in women with breast cancer. Participation in the study does not entail any additional treatment. The study will document the diagnostic tests and treatments performed or planned to date, the well-being of the newborn 4 weeks after delivery, and the health status of the mother and child 5 years after the start of treatment. Additionally, information will be collected from tumor tissue and placental tissue. For this purpose, data will be compared between two different groups. Group 1 consists of women with a first diagnosis of breast cancer during pregnancy, and Group 2 consists of women who are diagnosed with breast cancer before the age of 40 but are not pregnant at the time.

Women with a first diagnosis of breast cancer during pregnancy are eligible to participate in this study. Additionally, patients up to age 40 with a first diagnosis of breast cancer outside of pregnancy may participate in the study as a comparison group.

Facts

  1. What disease: Breast cancer (mammary carcinoma)
  2. Cancer characteristics: Diagnosis during pregnancy (Group 1) or outside of pregnancy (Group 2) at an age of under 40
  3. What the study investigates: Collection of data regarding diagnosis, treatment, pregnancy course, and disease progression
  4. Study objective: To improve understanding of breast cancer during pregnancy
  5. Study duration: approximately 5 years
  6. Study characteristics: purely observational, 2 groups; no new medications or therapies are being tested

Trial sites

25 trial sites in Germany are listed. Find a site near you.

  • Klinikum St. Marien Amberg

    Mariahilfbergweg 7, 92224 Amberg, Oberpfalz

    Recruiting
  • Klinikum Bamberg

    Bamberg

    Recruiting
  • Klinikum Bayreuth GmbH

    Bayreuth

    Recruiting
  • Klinikum Coburg GmbH

    Ketschendorfer Straße 33, 96450 Coburg

    Recruiting
  • Klinikum Darmstadt GmbH

    Darmstadt

    Recruiting
  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden

    Recruiting

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 (NCT00196833) 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.