Auch das Gesamtansprechen war h?her in der Margetuximab-Gruppe (22 vs. immunotherapy, an advantage for overall survival was able to be demonstrated in a subgroup (immune cells PD-L1-positive). The PARP inhibitor therapy for HER2-negative patients with a germ line mutation in BRCA1 or BRCA2 was also associated with an improved overall survival in a subgroup. These promising new study results are summarised in this review. strong class=”kwd-title” Key words: advanced breast cancer, metastases, therapies, mutation testing, immunotherapy Introduction The new developments in the therapy of advanced breast cancer are taking place at a rate which has never been seen before. While only few new drugs were approved by 2012, the approval of 10 new drugs has been able to be observed since then. These rapid developments call for a high degree of attention from all sides (patients, physicians, health insurance companies, health committees) to ensure therapeutic efficacy and patient safety. In this review article, we focus on the latest study results which were recently published or presented at national or international professional conferences. Metastatic HER2-negative, Hormone-Receptor-Positive Breast Cancer Many study designs currently OTS514 OTS514 concentrate on analysing the efficacy of inhibitors of the PI3K/AKT/PTEN signalling pathway 1 in patients with advanced breast cancer. Jones et al. investigated the significance of the AKT inhibitor capivasertib in combination with fulvestrant within the framework of the FAKTION study (phase II). A significant PFS advantage was seen (4.8 vs. 10.3 months) versus those patients who were treated only with fulvestrant, independent of an activation of the PI3K/AKT/PTEN signalling pathway. Likewise, improved overall survival C however not statistically significant C was seen on the endocrine combination therapy 2 . These results are promising and must be accordingly confirmed in a phase III study. New data from the MONALEESA-7 and MONALEESA-3 study In the premenopausal, metastatic situation as well, the use of CDK4/6 inhibitors in combination with a GnRH analogue is by now the therapeutic standard. The initial data on overall survival following 35 months of follow-up observation in the Monaleesa-7 study were recently published in full 3 . In this study, 672 premenopausal patients with hormone-receptor-positive, HER2-negative, metastatic breast cancer were treated with an endocrine combination therapy (non-steroidal aromatase inhibitor or tamoxifen plus ovarian function suppression) with or without the addition of ribociclib. The most current evaluation demonstrated a significant advantage in overall survival (HR?=?0.712; 95% CI: 0.54?C?0.95; p?=?0.00973) with an estimated survival rate after 42?months of 70.2 vs. 46.0%. The treatment following the study therapy did not differ between the arms. Thus the Monaleesa-7 study is the first study with a CDK4/6 inhibitor which demonstrates a survival advantage in the overall study population. Not reported or published during a conference but rather issued in a press release 4 , the Monaleesa-3 study 5 is the second study which is also said to have shown an advantage for overall survival. How great the effect is cannot yet be said due to the lack of any publication at this present time. New therapies as alternative to chemotherapies Another study on premenopausal patients was able to prove the significance of endocrine therapy in combination with CDK 4/6 inhibitors in the metastatic situation 6 . The Korean study KCSG-BR 15-10 compared chemotherapy with capecitabine with an endocrine therapy in 184 patients with metastatic disease. The patients in the endocrine CD3G therapy arm received exemestane plus a GnRH analogue in combination with palbociclib. All patients had previous therapy with tamoxifen, about 50% did not receive any previous therapy in the metastatic situation, about 20% had already received chemotherapy for the metastatic disease. The assessment revealed a significantly longer PFS for the endocrine combination than with OTS514 capecitabine (20.1 vs. 14.4 months, HR?=?0.659; 95% CI: 0.44?C?0.99). The advantage with regard to the PFS could be observed independently from previous chemotherapy. Other parameters such as the therapeutic response were comparable. For premenopausal patients, endocrine therapy in combination with a CDK4/6 inhibitor is just as effective as chemotherapy. These data support the recommendation of the AGO Mamma organ committee on the preferred use of endocrine therapy in the metastatic situation, even if the reality of therapy in Germany (and also other countries) does not yet entirely reflect this recommendation 7 . Compliance as the focus of antihormone therapies In a study from Germany, adherence data during aromatase monotherapy in patients with advanced breast cancer were recently published 8 . This study showed that after 12 months, approx. 40% of patients had discontinued therapy without progression if an adverse effect occurred in the first 30 days of therapy. This issue.