Klinische Studien und Innovative Therapien in der Frauenklinik

• ADAPTcycle / WSG-AM08
  Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing endocrine therapy plus ribociclib versus chemotherapy in intermediate risk, HR+/HER2- early breast cancer
  
  Studiendurchführung: Prof. Park-Simon/Frau Klein

• ADAPTlate / WSG-AM11
  A randomized, controlled, open-label, phase-III trial on Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) high risk, HR+/HER2- early breast cancer (ADAPTlate)
  
  Studiendurchführung: Prof. Park-Simon/Frau Klein

• ADAPTlate TraFo
  Translational Research Project ADAPTlate - Study: A randomized, controlled, open-label, phase-III trial on Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) high risk, HR+/HER2- early breast cancer (ADAPTlate)
  
  Studiendurchführung: Prof. Park-Simon/Frau Klein

• AXSANA / EUBREAST 3
  AXillary Surgery After NeoAdjuvant Treatment) A prospective multicenter cohort study to evaluate different surgical methods of axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy
  
  Studiendurchführung: Dr. Kühnle

• BCP / GBG 29 / NCT00196833GBG-29
  Prospektive und Retrospektive Registerstudie der German Breast Group (GBG) zur Diagnostik und Therapie des Mammakarzinoms in der Schwangerschaft mit jungen, nicht schwangeren Patientinnen (<40Jahre) als Vergleichskohorte.
  
  Studiendurchführung: Prof. Park-Simon/Herr Krentel

• BMBC / GBG 79
  Untersuchung von Resistenzmarkern bei Hirnmetasasen eines Mammakarzinoms im Kontext neuer Therapieschemata
  
  Studiendurchführung: Prof. Park-Simon/Frau Korotkaia

• DESTINY-Breast12 / T-DXd / AZD4552 / D9673C00007
  An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2 Positive Breast Cancer (DESTINY- Breast12)
  
  Studiendurchführung: Prof. Park-Simon/Herr Krentel

• ELEANOR / F-2020-019 / NIS07075
  Neratinib in patients with HER2+ breast cancer: a multi-centric, multi-national, prospective, longi-tudinal, non-interventional study in Germany and Austria
  
  Studiendurchführung: Prof. Park-Simon/Frau Klug

• EUBREAST-01 / GBG 104 / NCT04101851
  Omission of Sentinel Lymph Node Biopsy in Triple-negative and HER2-positive Breast Cancer Patients With Radiologic and Pathologic Complete Response in the Breast After Neoadjuvant Systemic Therapy: a Single-arm, Prospective Surgical Trial.
  
  Studiendurchführung: Dr. Kühnle/Dr. Gebauer

• Pro B
  PRO B – Patient-Reported Outcomes bei Brusterkrankungen. Neue Wege der Versorgung bei metastasiertem Brustkrebs.
  
  Studiendurchführung: Dr. Gebauer/Frau Dompke

• TROPION Breast 02 / D926PC00001
  A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato DXd) Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD 1/PD L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)
  
  Studiendurchführung: Prof. Park-Simon/Herr Krentel

• VF Mamma / Netzwerkstudie Mammakarzinom
  Genetische Prädikatoren des Therapieerfolges bei Patienten mit Brustkrebs
  
  Studiendurchführung: Prof. Park-Simon/Herr Krentel und AG Molekulare Gynäkologie des Forschungszentrums

• ZEST / ctDNA / 213831
  Randomized Phase 3 Double-Blinded Study Comparing Efficacy of Niraparib to Placebo in Participants with Either Triple-Negative Breast Cancer or HER2-neg BRCAmut Breast Cancer with Molecular Disease Based on Circulating Tumor DNA Levels after Definitive Therapy
  
  Studiendurchführung: Prof. Park-Simon/Frau Klug

 

In Vorbereitung

• CAPTOR-BC / CLEE011ADE07R / AGO-B-060
  Comprehensive analysis of spatial, temporal and molecular patterns of ribociclib efficacy and resisitance in advanced breast cancer patients

• HER2CLIMB-05 / SGNTUC-028
  A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)

• INAVO121 / WO43919
  A phase III, multicenter, randomized, open-label study evaluating the efficacy and safety of inavolisib plus fulvestrant versus alpelisib plus fulvestrant in patients with hormone receptor-positive, her2-negative, pik3ca mutated, locally advanced or metastatic breast cancer who progressed during or after cdk4/6 inhibitor and endocrine combination therapy

• OlympiaN / D931CC00001
  A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients with BRCA Mutations and Early Stage HER2-Negative Breast Cancer (OlympiaN)

• SURVIVE
  Standard Surveillance vs. Intensive Surveillance in Early Breast Cance

• GENDOK
  Genetische Disposition für Ovarialkarzinom
  
  Studiendurchführung: AG Molekulare Gynäkologie des Forschungszentrums

• MIROVA / AGO-OVAR 2.34
  A randomized phase II trial of Mirvetuximab soravtansine (IMGN853), in BRCA wild-type, folate receptor alpha (FRα)-positive recurrent ovarian cancer eligible for platinum-based chemotherapy.
  
  Studiendurchführung: Prof. Park-Simon/Frau Klug

In Vorbereitung

• AGO-OVAR 28 / ENGOT-ov57 / NCT05009082
  Niraparib vs Niraparib in combination with Bevacizumab in patients with carboplatinum-taxane based chemotherapy in advanced ovarian cancer (A multicentre randomised phase III trial

• PRIMA / AGO-OVAR 21
  Phase III Studie zur Wirksamkeit von Niraparib vs. Placebo bei Pat. mit HRD-positivem fortgeschrittenem OvCa nach Ansprechen (CR/PR) auf platinbasierte 1st-Line-CHT

• ECLAT / AGO-OP.6 / KKS 228
  (Endometrial Cancer Lymphadenectomy Trail) Pelvic and Paraaortic Lymphadenectomy in Patients with Stage I or II Endometrial Cancer with High Risk of Recurrence. A Multicenter, Prospective Randomized Controlled, Phase III Trail
  
  Studiendurchführung: Prof. Hillemanns/Frau Daitche

• ENDOGEN
  Genetische Disposition für Endometriumkarzinom
  
  Studiendurchführung: AG Molekulare Gynäkologie des Forschungszentrums

• ENDOMED
  Polymorphismus, Faktoren, genetische Variabilität und Prädisposition für Endometriose
  
  Studiendurchführung: AG Molekulare Gynäkologie des Forschungszentrums

In Vorbereitung

• AGO-TR 2
  Prävalenz somatischer Mutationen und Keimbahnmutationen bei Patientinnen mit primären oder rezidivierenden Endometriumkarzinom

• HaSCo-Studie
  Systematischer populationsbasierter Vergleich verschiedener häuslicher Selbstuntersuchungsmethoden zum HPV Abstrich im Rahmen der Zervixkarzinomprävention. prospektiv, prophylaktisch, monozentrisch, randomisiert, Biobank-/Biomarker-Studie (Hannoversche Self-Collection-Studie zur Prävention von Gebärmutterhalskrebs)
  
  Studiendurchführung: AG HPV-induzierte Neoplasien

• SENTICOL III / GINECO-CE106 / ENGOT-Cx4 / 2017-A00945-48 /KKS 297
  International validation study of sentinel node biopsy in early cervical cancer. (SENTICOL III). An international, prospective, randomized, multicenter, single blind trial to compare sentinel lymph node (SLN) biopsy versus SLN biopsy + pelvic lymphadenectomy in term of DFS and HR-QoL.
  
  Studiendurchführung: Prof. Hilemanns/Frau Daitche, Frau Kruppa, Prof. Klapdor

• ZerviGen
  Genetische Disposition für Dysplasien und Karzinome der Cervix uteri
  
  Studiendurchführung: AG HPV-induzierte Neoplasien und AG Molekulare Gynäkologie des Forschungszentrums

 

In Vorbereitung

• DelVIN / V-001
  A multicenter phase I trial evaluating the safety and preliminary efficacy of local decitabine treatment of human papillomavirus (HPV)-induced vulvar intraepithelial neoplasia (VIN) grade 2/3
  
  Studiendurchführung: Dr. Denecke

• BNT211-01
  Phase 1/2a, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors
  
  Studiendurchführung: Prof. Hillemanns, Prof. Könecke/Eilmann, Heutling