Clinical studies and innovative therapies

• 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
  
  Principal investigator: Dr. Kühnle

• BCP / GBG 29 / NCT00196833GBG-29
  Prospective and retrospective registry study of the German Breast Group (GBG) on the diagnosis and treatment of breast cancer during pregnancy with young, non-pregnant patients (<40 years) as a comparison cohort.
  
  Study management: Prof. Park-Simon / Ms. Slobodianiouk

• BMBC / GBG 79
  Investigation of resistance markers in brain metastases of breast cancer in the context of new treatment regimens
  
  Study management: Prof. Park-Simon / Ms. Slobodianiouk

• CAPItello-292 / D361DC00001
  A Phase Ib/III, Open-label, Randomized 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
  
  Principal investigator: Prof. Park-Simon / Ms. 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
  
  Principal investigator: Prof. Park-Simon / Ms. Zarwari

• 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
  
  Principal investigator: Prof. Park-Simon / Ms. Probst

• ELEMENT / GBG-114
  Phase II study evaluating the addition of elacestrant, an oral selective estrogen receptor degrader (SERD), to standard-of-care olaparib in patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutations
  
  Principal investigator: Prof. Park-Simon / Ms. Klug

• EvoPAR-Breast01
  A Randomized, 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
  
  Study conduct: Prof. Park-Simon / Ms. Zarwari

• MELODY
  A prospective non-interventional multicenter cohort study to investigate different imaging-guided techniques for the localization of malignant breast lesions
  
  Principal investigator: Dr. Kühnle

• 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
  
  Study management: Prof. Park-Simon / Ms. Klug

• SURVIVE
  Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer
  
  Study management: Prof. Park-Simon / Ms. Probst

• TREAT ctDNA
  Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse
  
  Principal investigator: Prof. Park-Simon / Ms. Probst

• 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)

Study conduct: Prof. Park-Simon / Ms. Zarwari

 

In preparation

• 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
  

• MoonROSE / GO46021
  A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating The Safety, Pharmacokinetics, And Activity Of GDC-4198 Alone And In Combination With Giredestrant In Comparison With Abemaciclib And Giredestrant In Participants With Locally Advanced Or Metastatic Estrogen Receptor-Positive, Her2-Negative Breast Cancer Who Have Previously Progressed During Or After A CDK4/6 Inhibitor
  

• MK2870-012
  A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

• GENDOK
  Genetic disposition for ovarian cancer
  
  Study conducted by: Molecular Gynecology Unit of the Research Center

• ASPIRE
  Influence of 4DryField® PH on pain development after laparoscopic endometrial resection
  
  Study management: Prof. Hillemanns / Ms. Steinhage

• ENDOGEN
  Genetic disposition for endometrial cancer
  
  Study management: Molecular Gynecology Group of the Research Center

• ENDOMED
  Polymorphism, factors, genetic variability and predisposition to endometriosis
  
  Study conducted by the Research Center's Molecular Gynecology Group

• ENDOFERT
  Pathomechanisms of infertility and impaired pregnancy outcomes in endometriosis
  
  Study management: Dr. Hachenberg and the Reproductive Medicine and Molecular Perinatology Research Group

• Endo-Age
  Age-related decidualization defects of endometrial stromal cells in women with advanced maternal age
  
  Study management: AG Reproductive Medicine and Molecular Perinatology

• 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
  
  Study management: Prof. Hillemanns / Dr. Fangmann / Ms Steinhage and Center for Clinical Trials (ZKS)

• ZerviGen
  Genetic disposition for dysplasia and carcinoma of the cervix uteri
  
  Study management: HPV-induced neoplasia working group and Molecular Gynecology working group of the research center

 

• 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
  
  Study management: Prof. Hillemanns and Prof. Könecke / Ms. Eilmann and Ms. Heutling