Study of the Influence of Lifestyle on the Risk of Developing Breast Cancer in Individuals with a Known Genetic Predisposition (BRCA1/2 Mutation)
- Gender
- Women
- Age
- 18 years and older
- Trial type
- Interventional
- Line of therapy
- all
- Phase
- —
What is this trial about?
Women with a BRCA1/2 mutation have a significantly increased risk of developing breast cancer over the course of their lives. Previous studies have shown that lifestyle factors (exercise, healthy diet) can have a positive impact on the risk of developing breast cancer or, in cases where the disease is already present, can favorably influence its course. The goal of the LIBRE-2 study is to investigate whether a specific lifestyle program affects the risk of and course of breast cancer in women with a known BRCA1/2 mutation. Women aged 18 and older with a confirmed BRCA1/2 mutation are eligible to participate.
Detailed description
Genetic factors play a significant role in breast cancer risk. A mutation in the BRCA1 or BRCA2 genes significantly increases the risk of developing breast or ovarian cancer over the course of a person’s lifetime.
Regardless of hereditary factors, breast cancer is treated—depending on the extent of the disease—with medication, surgery, and radiation therapy. Studies have also shown that lifestyle can influence both the risk of developing the disease and its progression. For non-hereditary breast cancer, it has been demonstrated that a healthy diet (Mediterranean diet), regular exercise, and a stable body weight can reduce the risk of developing the disease.
The LIBRE-2 study is now investigating these associations specifically in women with a hereditary BRCA1/2 mutation. To this end, two groups are being formed as part of the study: Participants in the intervention group take part in a 12-month program that includes structured physical exercise and a Mediterranean diet. This diet, which is rich in fruits, vegetables, whole grains, fish, and healthy fats, is considered particularly beneficial to health. The goal of the program is to motivate the women to make long-term lifestyle changes to reduce their risk of cancer. The control group, on the other hand, receives general information about healthy eating and exercise, but no specific guidance or supportive measures.
Assignment to one of the two groups is random. The program’s effectiveness is primarily assessed based on adherence to the diet, calculation of the body mass index (BMI), and improvements in physical fitness.
Women with a confirmed BRCA1/2 mutation who are at least 18 years old are eligible to participate. They may be healthy or may already have breast cancer. Participation is not possible if the participant is currently undergoing chemotherapy or if the cancer has already spread (metastases).
Facts
- What disease: Hereditary form of breast cancer
- Cancer characteristics: Healthy women or women with breast cancer who have a confirmed BRCA1/2 mutation; not currently undergoing chemotherapy; no metastases
- What the study examines: Effects of a structured lifestyle modification program (exercise, healthy diet) compared to information alone
- Study objective: To assess the influence of lifestyle on the risk and course of hereditary breast cancer
- Study duration: Evaluation after 12 months, with follow-up for a maximum of 3 years in total
- Study characteristics: Randomized, two groups (intervention and control)
Trial sites
19 trial sites in Germany are listed. Find a site near you.
Humboldt-Universität zu Berlin
Berlin
RecruitingUniversitätsklinikum Carl Gustav Carus Dresden
Dresden
RecruitingUniversitätsklinikum Düsseldorf
Moorenstr. 5, 40225 Düsseldorf
RecruitingKEM I Evang. Kliniken Essen-Mitte gGmbH
Essen
RecruitingUniversitätsklinikum Essen
Essen
RecruitingUniversitätsklinikum Freiburg
Freiburg
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.
- 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 (NCT02516540) 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.


