Klinische Studien und Innovative Therapien

• 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 Klug

• 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 / Frau Klug

• BMBC / GBG 79
  Untersuchung von Resistenzmarkern bei Hirnmetasasen eines Mammakarzinoms im Kontext neuer Therapieschemata
  
  Studiendurchführung: Prof. Park-Simon / Frau Klug
   
• CAPItello-292 / D361DC00001
  A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
  
  Studiendurchführung: Prof. Park-Simon / Frau Zarwari

• CAPTOR-BC / CLEE011ADE07R / AGO-B-060
  Comprehensive analysis of spatial, temporal and molecular patterns of ribociclib efficacy and resisitance in advanced breast cancer patients
  
  Studiendurchführung: Prof. Park-Simon / Frau Zarwari
   
• EvoPAR-Breast01
  A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer
  
  Studiendurchführung: Prof. Park-Simon / Frau Klug

• MELODY
  Eine prospektive nicht-interventionelle multizentrische Kohortenstudie zur Untersuchung unterschiedlicher bildgebungsgesteuerter Techniken zur Lokalisation von malignen Brustläsionen

In Vorbereitung

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

• ELECTRA / ELA-0121
  An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer

• ELEGANT
  Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study

• INAVO123
  Phase III, multicenter, randomized, double-blind, placebo-controlled study, evaluating the efficacy and safety of the triplet combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i; palbociclib) and letrozole versus placebo plus a CDK4/6i (palbociclib) and letrozole in the first-line setting in patients with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR), human epidermal growth factor receptor 2-negative (HER2), advanced breast cancer (ABC)
   
• IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Treatment of Physician’s Choice in Patients with Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple negative Breast Cancer (TNBC) or ER-low, HER2-negative BC who are Ineligible for Anti-PD1/PD-L1 Treatment
   
• REMULADE: Real world mutational landscape detected by ctDNA analysis in patients with metastatic breast cancer (MBC) progressing on/after CDK4/6i & aromatase inhibitor (AI) based therapies
   

• TREAT ctDNA: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse

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

• Ascent-GYN-01 / GS-US-682-6769
  A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
  
  Studiendurchführung: Prof. Park-Simon / Frau Klug
   
• 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
 

• ASPIRE
  Einfluss von 4DryField® PH auf die Schmerzentwicklung nach laparoskopischer Endometrioseresektion
  
  Studiendurchführung: OP-Studienteam

• G-LACC (German-funded Laparoscopic Approach to Cervical Cancer)
  A randomized clinical trial comparing laparoscopic or robot-assisted radical hysterectomy versus abdominal radical hysterectomy in patients with early-stage cervical cancer
  
  Studiendurchführung: Prof. Hillemanns / Dr. Fangmann /  Frau Steinhage  und  Center for Clinical Trials (ZKS)

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

 

In Vorbereitung
 

• MK-2870-020 / ENGOT-CX 20 / AGO-ZX 5
  A Phase 3 Randomized, Active-controlled, Open-Label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-Line or Third-Line Treatment for Participants with Recurrent or Metastatic Cervical Cancer

• 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 und Prof. Könecke / Frau Eilmann und Frau Heutling