Breast Centre Cologne-Holweide, Cologne

Successful treatment of breast cancer depends on many years of experience, the highest level of medical expertise, the use of the latest therapeutic developments and adherence to quality standards in medical care. The Breast Centre Cologne-Holweide in Cologne, headed by Priv. Doz. Dr. med. Mathias Warm, meets all of these requirements in full. The clinic treats women with gynaecological cancers as well as other gynaecological conditions. Dr Warm's record includes many years of work in senior positions in gynaecology and gynaecological oncology, as well as research work.

The Breast Centre Cologne-Holweide in Cologne is currently taking part in 11 clinical research projects investigating the efficacy and tolerability of new medicines and of surgical and conservative methods of treating malignant breast disease. All clinical trials are conducted in strict accordance with the legislation governing the approval of new medicines and treatment methods.

A fundamental distinction is drawn here between preclinical research (laboratory studies and animal experiments), clinical drug trials, which establish the effects of a drug in humans, and so-called therapy optimisation studies, which are aimed at further refining treatment methods.

Clinical drug trials, and therefore the first use of a drug in humans, are possible only if the results of preclinical research are encouraging. A clinical trial is carried out in three stages (I-III): a drug cannot be approved until all three phases have been successfully completed one after the other.

Once a drug has been approved for testing in humans, testing can continue in the form of so-called phase IV studies.

The aim of therapy optimisation studies is to improve patients' chances of recovery or their quality of life.

Treatments of proven efficacy are used in different sequences, with different dosing regimens or drug combinations. Because the difference from standard therapy is not very great, the risk to patients taking part in phase IV optimisation studies is low.

In addition to clinical trials there are also non-interventional studies (NIS), which are often referred to as observational studies. These studies usually collect additional data on medicines that have already been approved: the focus here is frequently on possible side effects and tolerability. The purpose of an NIS is therefore to observe, document and evaluate as many patients as possible who are taking new medicines.

As a study participant you can be confident that you will not be exposed to unnecessary risk: the risks to you as a patient are precisely assessed and must be weighed against the possible benefits. A study has to be carefully planned and set out in a study protocol that is strictly followed. Only doctors with specific expertise are permitted to conduct clinical trials.

As a rule, your treating doctor will recommend taking part in a study if he or she considers it will be of benefit to you. If you have cancer, all the specialists involved in your treatment will discuss at a tumour board meeting whether your participation in a clinical trial is possible and appropriate.

Before deciding whether to take part in a study, talk to your doctor. You will also receive written information about the study. If you decide to take part, you will sign a consent form together with your doctor. If you decide not to take part, you will of course continue to receive treatment with the best established therapy available.

If you no longer wish to take part in a study, you may withdraw your consent at any time without having to fear any adverse consequences.

Participation in a study is always voluntary and free of charge. Studies are funded either by the manufacturer of the medicine or by independent organisations such as the German cancer charity Deutsche Krebshilfe e.V. or the German Research Foundation.

Diagnostics at the Breast Centre Cologne-Holweide:

• consultations on breast disease and the development of a concept for
• surgical diagnosis and treatment;
• ultrasound diagnostics;
• digital mammography;
• MRI diagnostics;
• ultrasound-guided fine-needle aspiration biopsy of the breast and axillary lymph nodes;
• ultrasound-guided core needle biopsy of the breast;
• stereotactic vacuum-assisted breast biopsy with three-dimensional reconstruction
• vacuum-assisted biopsy under MRI and X-ray guidance;
• "needle-gun" biopsy;
• examination and palpation of the breast and lymphatic ducts;
• 3D and 4D breast sonography;
• high-resolution ultrasound of the breast and lymphatic ducts;
• contrast-enhanced magnetic resonance imaging (MRI) of the breasts;
• stereotactic vacuum-assisted biopsy;
• bone scintigraphy;
• scintigraphy of the lymph nodes and lymph vessels;
• PET-CT;
• protease analysis of fresh tumour tissue;
• immunohistochemical testing of oestrogen receptor expression.

In 80% of cases the results of sonography and mammography agree — in 10% of cases they do not. Cystic changes and other benign tissue changes can therefore often be differentiated better by ultrasound, whereas microcalcifications are detected better by mammography.

The Breast Centre Cologne-Holweide offers counselling within the FertiPROTEKT project on preserving fertility before and after chemotherapy or radiotherapy in line with the latest scientific evidence and, where necessary, on measures to protect reproductive function.

Many individual factors are taken into account in the surgical treatment of breast cancer. The decisive factors are the patient's safety, the size of the breast, the patient's own wishes (for example breast-conserving surgery with radiotherapy, or total mastectomy), the patient's other medical conditions and her professional and domestic circumstances (whether breast reconstruction procedures are advisable).

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