Germline BRCA1 and BRCA2 mutations enable targeted therapies in human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC). The two poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors olaparib and talazoparib were introduced into clinical practice in 2018. Limited evidence about their routine clinical use highlights the importance of this analysis. We provide a real-world analysis for PARP-inhibitor use in ABC patients treated within the prospective German PRAEGNANT registry (NCT02338167). 152 patients with ABC receiving a PARP-inhibitor were included. Real-world progression-free survival (rwPFS) and real-world overall survival (rwOS) were calculated for all patients using the Kaplan-Meier method. Subgroups (line of therapy, metastasis timing, hormone receptor (HR) status, treatment: olaparib, talazoparib, among others), germline BRCA1, BRCA2 and PALB2 mutations and adverse events (AEs) were analyzed. The median rwPFS was 6.2 months (95% CI, 4.8-7.9) and the median rwOS was 17.1 months (95% CI, 14.4-22.3). Line of therapy, HR status and treatment (olaparib versus talazoparib) appeared to especially affect both rwPFS and rwOS. Among patients with a reported germline mutation, 36.1% had a BRCA1, 62.9% a BRCA2 and 1.0% a PALB2 mutation. In summary, outcomes were comparable to those reported in pivotal trials despite later-line use of PARP-inhibitors in this analysis.

Background: The “International Consensus Conference for Advanced Breast Cancer” was initiated with the rationale to standardize treatment of advanced breast cancer (ABC) based on available evidence. The aim was to ensure that all ABC patients worldwide receive adequate treatment and get access to new diagnostic, therapeutic, and supportive options. Topics of ABC8: Since the beginning ABC Consensus Conference has been organized in Lisbon/Portugal. The 8th International Consensus Conference for ABC (ABC8) took place there from November 4th to 8th, 2025, and focused not only on metastatic disease but also on locally advanced and inflammatory breast cancer (BC). Special topics were new drugs and new therapies with promising results in randomized clinical trials. Not all of them are currently approved by FDA (Food and Drug Administration) or EMA (European Medicines Agency) for the indication in which the study was conducted. As in previous years, patient advocates from around the world were integrated into the ABC Conference and contributed substantially to the consensus. Rationale for the Manuscript: A German BC expert panel comments on the voting results of the ABC8 panelists regarding their relevance for routine clinical practice in Germany. As with previous meetings, the ABC8 votes focused on modified or new statements. Statements not modified for the ABC8 consensus remain valid. The German comments are always based on the current recommendations of the “Breast Committee” of the Gynecological Oncology Working Group (Arbeitsgemeinschaft Gynäkologische Onkologie, AGO Mamma).

Granulosazelltumoren (GCT) des Ovars entstehen aus dem Ovarialmesenchym und den Keimsträngen und machen 70

PurposeMutations in PIK3CA are one of several actionable mutations for patients with hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Alpelisib in combination with fulvestrant was the first approved PI3K inhibitor and was introduced in clinical practice in 2019. A lack of evidence for the use of alpelisib in the context of current treatment options like cyclin-dependent 4/6 inhibitor (CDK4/6i), highlights the importance of this analysis. We provide a real-world analysis of the use of alpelisib with the prospective German PRAEGNANT registry (NCT02338167).Methods57 patients with advanced breast cancer receiving alpelisib and fulvestrant were identified. 55 Patients had received prior CDK4/6i therapy. Progression-free survival (PFS) and overall survival (OS) were calculated for all patients, and stratified according CDK4/6i pre-treatment, using the Kaplan-Meier method. Subgroups (age, line of therapy, concomitant disease among others), somatic PIK3CA mutations, reasons for discontinuation and adverse events (AEs) were analyzed.ResultsThe median PFS was 5.0 (95% confidence interval [CI], 3.1-9.4) months, and the median OS was 20.1 (95% CI, 14.6-30.8) months. Line of therapy and concomitant diseases appeared to affect PFS, while the line of therapy and preexisting diabetes influenced OS. However, subgroups were too small for statistical testing. Discontinuation was mainly due to tumor progression (56.1%). Hyperglycemia, rash and diarrhea were the most documented AEs.ConclusionThis prospective real-world analysis shows slightly shorter median PFS and OS times compared with the pivotal trials. Patients in our analyses received alpelisib in later therapy lines, which may explain the poorer outcome.

Granulosa cell tumors (GCT) of the ovary arise from the ovarian mesenchyme and sex cords and account for 70% of all sex cord stromal tumors but less than 3% of all ovarian neoplasms. Characteristic for these tumors is their ability to secrete estrogens (less frequently androgens and progestogens) as well as their tendency to recur many years after initial excision, sometimes 10-20 years later. The recurrence rate is around 30%. Due to the estradiol produced by the tumor, these tumors can be associated with abnormal vaginal bleeding at an early stage. The standard treatment in the early stages is surgical removal of the tumor. The majority of these patients (78-91%) are in stage I when the cancer is diagnosed and 10-year survival rates of 84-95% can be achieved by surgery alone. In contrast, the prognosis for 10-year survival is considerably worse in advanced stages or cases of recurrence. If the tumor is unresectable, platinum-based chemotherapy is usually employed, although with conflicting results. Because GCTs are radiation-sensitive, radiotherapy is also used for treatment. To improve disease-free survival, overall survival and quality of life, alternative treatment strategies are needed. As germ cell tumors typically express steroid hormone receptors, hormone therapy has been proposed as a potential treatment option, with some promising results.

INTRODUCTION:Whereas CDK4/6 inhibitors (CDK4/6i) are the standard first-line therapy for patients with hormone receptor-positive (HRpos), HER2-negative (HER2neg) metastatic breast cancer, guidelines on treatment options after progression on CDK4/6i are more diverse. Chemotherapy is recommended if a patient develops endocrine resistance or experiences a visceral crisis. However, the impact of the choice of chemotherapy remains unknown. METHODS:HRpos/HER2neg patients who received first-line CDK4/6i, followed by second-line chemotherapy (N = 215) were selected from the prospective PRAEGNANT registry (NCT02338167). Cox regression analyses were used to evaluate the correlation between the choice of chemotherapy (capecitabine monotherapy, capecitabine + bevacizumab, taxane monotherapy, taxane + bevacizumab, anthracycline, other chemotherapeutics) and progression-free survival (PFS) and overall survival (OS). RESULTS:Patients who received second-line chemotherapy mostly had high-grade tumors (G2: 62.3 %, G3: 33.3 %), visceral metastases (62.3 %) and developed metastatic disease following a primary breast cancer diagnosis (73.8 %). Capecitabine was the most common regimen (25.1 %), followed by taxane + bevacizumab (17.2 %). When adjusting for other prognostic factors (age, BMI, grading, ECOG, metastasis group and time to metastases), the choice of chemotherapy did not influence PFS (p = 0.16) nor OS (p = 0.47). Adjusted hazard ratios for PFS were lowest in regimens with bevacizumab (capecitabine as reference; capecitabine + bevacizumab: 0.53 (95 %CI: 0.29, 0.97); taxane + bevacizumab: 0.64 (95 %CI 0.35, 1.15)). CONCLUSION:Although the choice of chemotherapy post-CDK4/6i did not significantly affect PFS or OS, combinations with bevacizumab may have some benefit. Nevertheless, considering side effects may be most important when choosing the type of second-line chemotherapy.

The use of CDK4/6 inhibitors, the new PI3K/AKT-kinase inhibitors, selective estrogen receptor-degraders (SERDs), antibody-drug conjugates, immune therapies and PARP inhibitors in recent years has resulted in a marked change in the therapy landscape for patients with advanced stage breast cancer. CDK4/6 inhibitors, trastuzumab deruxtecan, and sacituzumab govitecan have all been shown to provide significant overall survival benefits compared to conventional chemotherapy. Other substances are also showing promising results and hold out the hope that further analysis of the overall survival benefits will be available in the near future. The speed at which studies are now being carried out has markedly increased, and conferences and specialist journals are now constant sources of new information. This review summarizes the most recent publications and conference presentations on the treatment of patients with advanced stage breast cancer.

Background: RESCUE is a prospective, international, multicenter health care study on risk assessment by the clinicomolecular test EndoPredict® and long-term patient outcome in early luminal breast cancer. For patients (pt) with early luminal breast cancer, precise national and international guidelines on (neo)adjuvant systemic therapy exist. Nevertheless, especially regarding endocrine therapies, treatment landscape has been shown to be heterogeneous in real world. Objective: By analyzing baseline and follow up data from RESCUE, we describe the current (neo)adjuvant treatment landscape for pt with ER+ HER2neg early-stage breast cancer including: type of endocrine agents used, addition of GnRH analogs (GnRHAa)/ovarian function suppression (OFS) to ET in premenopausal pt, use of chemotherapy and use of bone modifying agents (Bisphoshonates or Denosumab) in the adjuvant setting. Methods: Data from pt, who entered the RESCUE trial between July 2018 and September 2022 at 45 (42 German/3 Swiss) breast centers were collected via electronic case report forms. Pt were eligible, if they had been diagnosed with HR+/HER2- primary invasive breast cancer stage I/II, T1 to T3 with 0 to 3 positive lymph nodes and if they had an EndoPredict®-test within six months before inclusion. Results: 1143 pt were analyzed. Median age was 57,0 years (range26,0-82,0). 614 pt(53,7%) were classified as pN0. Tumor-Grading was reported as follows: G1 (137pt, 12,0%), G2 (893pt, 78,1%), G3 (111pt, 9,7%). Distribution of Ki-67 was recorded as follows: £10% (228pt, 20,0%), 11-24% (162pt, 14,2%), 325% (753pt,65,9%). Of the 1134 female pt, 394 were premenopausal and 734 postmenopausal. Systemic treatment recommendations given by the centers´ documented tumor board decisions were as follows: 62,9% (n=248) of premenopausal pt and 61,0% (n=448) of postmenopausal pt were recommended to undergo (neo)adjuvant Chemotherapy (CTX). In the premenopausal cohort, the choice of ET recommendation included an GnRHa/OFS in 14,5% of cases (57pt). In these 57 pt, GnRHa/OFS was recommended to be combined with an aromatase inhibitor as initial ET in 15 cases (3,8% of premenopausal pt) and with tamoxifen in 41 cases (10,4% of premenopausal pt). 47 pt (82,5%) of the 57 pt with GnRHa/OFS-recommendation and 183 pt (54,3%) of the 337 pt without GnRHa/OFS-recommendation were recommended to undergo (neo)adjuvant CTX. Bone modifying agents (Bisphosphonates or Denosumab) were recommended in 10,2% of premenopausal and 32,7% postmenopausal pt. Follow up data on actually received ET (including +/- GnRH) and CTX (including +/- anthracyclines) will be presented in detail. Conclusion: These real world data show that in spite of existing guideline recommendations for the use of GnRHa/OFS in premenopausal women with early luminal breast cancer at higher risk for relapse, this is not routinely implemented. Therefore, regarding the ET recommendation, this patient cohort might be undertreated. Follow up data on actually received ET (including +/- GnRH) and CTX (including +/- anthracyclines) will be presented in detail. Sponsor: The study is sponsored by the North-Eastern-German Society of Gynecological Oncology (NOGGO) e.V. Citation Format: Johannes Ettl, Evelyn Klein, Christine Heinz, Ji Young Kim, Jens-Uwe Blohmer, Carsten Denkert, Stefan Paepke, Christine Mau, Katja Gnausch, Jasmin Yamamoto, Sven-Thomas Graßhoff, Tilmann Lantzsch, Cornelia Meisel, Kay Friedrichs, Andreas Schnelzer, Stephan Seitz, Axel Gatzweiler, Sirrka Kluge, Markus Borner, Pamela Lammert, Anke Kleine-Tebbe, Anja Pelzl, Dorothea Fischer, Amelie Bletscher, Christian Schindlbeck, Carmen Schade-Brittinger, Michael Wittenberg, Marion Kiechle. Current Endocrine/Systemic Treatment Landscape of ER+ HER2 negative early-stage Breast Cancer: First Data from the RESCUE trial [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P1-11-10.

Mit den CDK4/6-Inhibitoren, den neuen PI3K/AKT-Kinase-Inhibitoren, den selektiven Östrogenrezeptor-Degradern (SERDs), den Antikörper-Wirkstoff-Konjugaten, den Immuntherapien und den PARP-Inhibitoren wurde die Therapielandschaft von Patientinnen mit fortgeschrittenem Mammakarzinom in den letzten Jahren deutlich zum Positiven verändert. CDK4/6-Inhibitoren, Trastuzumab-Deruxtecan und Sacituzumab-Govitecan haben zudem alle einen signifikanten Gesamtüberlebensvorteil gegenüber konventioneller Chemotherapie nachgewiesen. Weitere Substanzen zeigen ebenfalls vielversprechende Daten, die hoffen lassen, dass in naher Zukunft weitere Analysen mit einem Gesamtüberlebensvorteil vorliegen. Die Geschwindigkeit der Studiendurchführung hat deutlich zugenommen, sodass die Kongresse zusammen mit den Fachzeitschriften eine stetige Quelle neuer Informationen bieten. Diese Übersichtsarbeit fasst die jüngsten Veröffentlichungen und Kongresspräsentationen über die Behandlung von Patientinnen mit fortgeschrittenen Stadien einer Mammakarzinomerkrankung zusammen.

Background: The "WAVES" (Widening Aims and giving patients a Voice for Expanded Structures in breast cancer care jointly developed by patients and physicians) study primarily aims to assess current care structures for breast cancer with a special focus on physician-patient-communication. In the long term, an improved Patient-Centered Communication-Care Concept (PCCCC) for breast cancer will be developed. WAVES is conducted within and funded by the BZKF (Bayerisches Zentrum für Krebsforschung, Bavarian Cancer Research Center) Network. Methods: The study is structured as a two-part questionnaire for breast cancer patients and a corresponding questionnaire for physicians. Here, we present the first results of the first-part questionnaire for patients regarding the duration of the first diagnosis consultation and satisfaction with this conversation based on the evaluation of 1000 participants. Results: Participants were between 23 and 89 years old (mean: 59.18 years), and mostly female (98%). More than every second patient felt shocked by the first diagnosis of breast cancer (54.8%). There was a significant association between longer initial consultation duration and higher patient satisfaction (p < 0.001). If the conversation lasted more than 30 minutes, 90.1% of the patients rated the duration as "just right", whereas only 12.7% rated “just right” in case of 10 minutes duration. With a first consultation lasting 30 minutes or longer, patients stated more frequently that they felt better informed (p<0.001), had fully or substantially understood the content (p < 0.001) and felt well prepared for further treatment decisions (p < 0.001). Conclusions: These results show a significantly higher satisfaction and better preparation of patients with initial breast cancer diagnosis if the initial consultation with a physician lasted 30 minutes or more. The need for improved communication structures, offering breast cancer patients appropriate time frames, has thus been clearly demonstrated by the cross-sectional survey of the WAVES study. Yet, this need for longer conversations not reflected in the current reimbursement structure. However, study results such as these show a clear need to integrate this in the future in order to ensure optimal care for breast cancer patients. Citation Format: Nina Ditsch, Melitta B. Koepke, Renate Haidinger, Brigitte Welter, Ute-Susann Albert, Christoph Aulmann, Traudl Baumgartner, Stefanie Corradini, Christian Dannecker, Johannes Ettl, Nadia Harbeck, Anne Herrmann-Johns, Christian Hinske, Marion Kiechle, Alkomiet Hasan, Klaus E. Jopp, Monika Klinkhammer-Schalke, Oliver Koelbl, Inaki Soto-Rey, Christoph Jung, Olaf Ortmann, Anna Rubeck, Gernot Müller, Verena Schmid, Frank Kramer, Franziska Feiler, Eva Schildmann, Stephan Seitz, Miriam Reicherts, Nadja Will, Achim Woeckel, Eva Schumacher-Wulff, Carl-Mathis Wild, Verina Wild, Carolin C. Hack, Rachel Wuerstlein, Susanne Kinnebrock, Miriam Kunz, Peter A. Fasching, Stefan Schiele, Matthias W. Beckmann. First results of the WAVES study: Significant increase of patient satisfaction with longer initial consultation duration for breast cancer diagnosis [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P1-10-04.

Background: Patients with first-line metastatic breast cancer (MBC) comprise patients with de novo metastases (dnMBC) or recurrent disease after primary breast cancer (rMBC). This analysis aimed to explore the prognostic value of dnMBC versus rMBC overall and particularly in subgroups according to age and metastasis site, in addition to other prognostic clinicopathological parameters in a first-line, hormone receptor (HR)-positive, HER2-negative (HRpos/HER2neg) population. Methods: Within the prospective PRAEGNANT MBC registry (NCT02338167), 508 HRpos/HER2neg patients, receiving first-line treatment for advanced disease, were identified. Clinicopathological parameters (age, body mass index, performance status, tumor grading, metastasis site and therapy) were assessed according to metastatic status (dnMBC, rMBC within 5 years of primary diagnosis (rMBC <5 years), rMBC after more than 5 years (rMBC >= 5 years)). Cox regression analyses were performed to investigate whether metastatic status influences progression-free survival (PFS) and overall survival (OS). Results: De novo metastatic disease was present in 180 patients (35.4 %), whereas 132 patients (26.0 %) had rMBC <5 years and 196 patients (38.6 %) had rMBC >= 5 years. Patients with dnMBC had the most favorable prognosis. Relative to dnMBC, hazard ratios for PFS were 1.75 (95%CI: 1.31-2.34) in rMBC<5 years and 1.25 (95%CI: 0.94-1.65) for rMBC >= 5 years. Subgroup-specific differences were not observed. Conclusion: HRpos/HER2neg first-line MBC patients have a more favorable prognosis if the disease was previously not treated. This difference was similar across all examined clinicopathological parameters. It may therefore be beneficial to incorporate MBC categories as a stratification factor in clinical trials.

This review summarizes the latest developments for the treatment of patients with early-stage breast cancer. Most of the clinically relevant changes were the result of using immune checkpoint inhibitors to treat patients with triple-negative breast cancer (TNBC) and CDK4/6 inhibitors to treat patients with hormone receptor-positive, HER2-negative (HRpos/HER2neg) tumors and a high risk of recurrence. Recent studies are presenting more and more data with long follow-up times and integrating translational analyses to evaluate new biomarkers such as circulating tumor DNA (ctDNA). This review article summarizes the latest developments published in recent months and puts the findings in context.

Das Mammakarzinom des Mannes („male breast cancer“, MBC) ist eine seltene, aber regelmäßig in den Brustzentren zu behandelnde Erkrankung. 1

The rationale behind the "International Consensus Conference for Advanced Breast Cancer" (ABC) is to standardize the treatment of patients with advanced or metastatic breast cancer worldwide using an evidence-based approach. The aim is also to ensure that patients in all countries receive adequate treatment based on current treatment recommendations and standards. The 7th International Consensus Conference on Advanced Breast Cancer (ABC7) took place from November 9 to 12, 2023 in Lisbon/Portugal. ABC7 focused on metastatic disease as well as on locally advanced and inflammatory breast cancer. Special topics included the treatment of oligometastatic patients, leptomeningeal disease, treatment of brain metastases, and pregnant women with ABC. As in previous years, patient advocates from all over the world participated in the consensus conference and were involved in decision making.

Background: The “International Consensus Conference for Advanced Breast Cancer” was initiated more than 10 years ago. The rationale was to standardize treatment of advanced breast cancer (ABC) based on available evidence and to ensure that all ABC patients worldwide receive adequate treatment and access to new therapies. Topics of ABC7: The 7th International Consensus Conference for ABC (ABC7) took place from November 9 to 11, 2023 – as in previous years in Lisbon/Portugal. ABC7 focused not only on metastatic disease but also on locally advanced and inflammatory breast cancer. Special topics were the management of oligometastatic disease, leptomeningeal disease, brain metastases, and pregnant women with ABC. Due to the current situation worldwide, there was a special interest to patients living in conflict zones. As in previous years, patient advocates from around the world were integrated into the ABC conference and had a major input to the consensus. Rationale for the Manuscript: A German breast cancer expert panel comments on the voting results of the ABC7 panelists regarding their relevance for routine clinical practice in Germany. As with previous meetings, the ABC7 votes focused on modified or new statements. Regarding the statements not modified for the ABC7 consensus, they are discussed in the published manuscript from 2021 in which the German experts commented on the ABC6 consensus. The German comments are always based on the current recommendations of the “Breast Committee” of the Gynecological Oncology Working Group (Arbeitsgemeinschaft Gynäkologische Onkologie, AGO Mamma).

BackgroundThe 7th "International Consensus Conference on Advanced Breast Cancer" (ABC) met from 9-12 November 2023 in Lisbon, Portugal. The consensus is organized by a group of experts from different countries and disciplines. RationaleThe rationale of the international consensus conference is to standardize the treatment of patients with primarily inoperable, locally advanced or with metastatic breast cancer worldwide on an evidence-based basis and to ensure that adequate therapy is possible in all countries. This manuscript discusses the on-site voting results of the ABC7 panel for everyday clinical practice in Germany. BasisThe discussion is related to the German guidelines of the "Arbeitsgemeinschaft Gyn & auml;kologische Onkologie" (AGO Organkommission Mamma, Version 2024.1D) which is updated annually, most recently in March 2024. ResultsIn this manuscript, the focus is on systemic treatment of patients with metastatic cancer. Special topics included the treatment of patients with oligometastases, leptomeningeal disease, and brain metastases and of pregnant patients. As in previous years, patient representatives from all over the world took part in the conference and were involved in reaching consensus.

Die Immuntherapie nimmt auch in der gynäkologischen Onkologie und in der Senologie einen immer größeren Teil der täglichen Behandlungen ein. Diese Übersichtsarbeit auf der Basis einer Literaturrecherche informiert über die Anwendung von Immuncheckpointinhibitoren (ICI) in der Praxis. Es werden wesentliche Hintergründe und Besonderheiten der Immuntherapie und der in der Gynäkologie relevanten ICI im Rahmen der jeweiligen Tumorentität aufgezeigt.