Klinische Studien und Innovative Therapien in der Frauenklinik

• Ascent-07 / GS-US-598-6168
  A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
  
  Studiendurchführung: Prof. Park-Simon / Frau Huber
   
• 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

• 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 Slobodianiouk

• 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 Maaßen

• 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

• 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)
  
  Studiendurchführung: Prof. Park-Simon / Frau Klein

• 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
  
  Studiendurchführung: Prof. Park-Simon / Frau Klug

In Vorbereitung

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

• 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

• 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

• TROPION-Breast04 / D926QC00001
  A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

• 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

• AGO-TR 2
  Prävalenz somatischer Mutationen und Keimbahnmutationen bei Patientinnen mit primären oder rezidivierenden Endometriumkarzinom
  
  Studiendurchführung: Prof. Hillemanns / Dr. Krause

• 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

• 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  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

• 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