Clinical Trials

Gynecological Tumors

Recruitment stopped
Ongoing Recruitment

Ovarial and Cervix Carcinomas

APROVE

(adjuvant, radiologisch)
Title:Adjuvante Protonentherapie des Zervix- und Endometriumkarzinoms
Indication:Zervixkarzinom
Type of study:Phase II
Contact: Dr. med. Nathalie Arians (Kontaktperson)
[nathalie.arians@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Klaus Herfarth (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03184350
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

NCT-PMO-1603 TOP-ART

(second-line, BRCAness)
Title:A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies
Indication:Krebs mit DNA-Reparatur-Defizite
Type of study:Phase II
Contact: Barbara Stöhr (Study Nurse)
[barbara.stoehr@nct-heidelberg.de]
Investigator: Prof. Dr. Stefan Fröhling (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03127215
EudraCT: 2017-001755-31 (siehe EU klinisches Studienregister)

Studie I "Chemotherapie"

(diagnostisch, Früherkennung, Screening)
Title:Chemotherapie-induzierte Veränderungen in der diffusionsgewichteten MRT (DWI) bei Patientinnen mit Ovarialkarzinomen
Indication:Eierstockkrebs
Type of study:Phase N/A
Contact: Radiologie, DKFZ (E10) (Kontaktperson)
[-]
Investigator: Dr. med. Theresa Mokry (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Studie II "Ovarialläsionen"

(diagnostisch, Früherkennung, Screening)
Title:Charakterisierung sonografisch unklarer Ovarialläsionen hinsichtlich ihrer Dignität insbesondere mittels diffusionsgewichteter MR Bildgebung
Indication:Abklärung unklarer Ovarialläsionen
Type of study:Phase N/A
Contact: Radiologie, DKFZ (E10) (Kontaktperson)
[-]
Investigator: Dr. med. Theresa Mokry (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Studie III "Staging-Studie"

(diagnostisch, Früherkennung, Screening)
Title:Beurteilung gynäkologischer Beckentumoren mittels MRT
Indication:Beurteilung von Eierstockkrebs mittels MRT
Type of study:Phase N/A
Contact: Radiologie, DKFZ (E10) (Kontaktperson)
[-]
Investigator: Dr. med. Theresa Mokry (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

C-PATROL

(epidemiologisch)
Title:C-PATROL-Einarmige, prospektive Nicht-interventionelle Studie zur Erfassung von klinischen Therapiedaten und Lebensqualitätsdaten von Patientinnen mit platinsensitivem, BRCA-mutierten Ovarialkarzinomrezidiv unter Olaparibtherapie
Indication:Ovarialkarzinom
Type of study:Phase N/A
Contact: Manuela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Prof. Dr. Frederik Marmé (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02503436
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

AGO- Ovar 2.29

Title:Atezolizumab in Kombination mit Bevacizumab und Che-motherapie versus Bevacizumab und Chemotherapie in rezidivierendem Ovarialkarzinom – eine randomisierte Phase III Studie
Indication:Ovarialkarzinom
Type of study:Phase III
Contact: Manuela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Prof. Dr. Frederik Marmé (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03353831
EudraCT: 2017-000202-37 (siehe EU klinisches Studienregister)

OPTIMISE-1

Title:Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation
Indication:Strahlentherapie mit potenziell kurativer Absicht eines primär thorakalen oder Beckenziels.
Type of study:Phase N/A
Contact: Dr. med. Rami El-Shafie (Kontaktperson)
[Rami.Elshafie@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Jürgen Debus (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03168048
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

OReO

Title:A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy.
Indication:Ovarian NeoplasmsNeoplasms, Glandular and Epithelial
Type of study:Phase III
Contact: Manuela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Prof. Dr. Frederik Marmé (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03106987
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Breast Cancer

BENEFIT

(neoadjuvant, supportive care trial, Sport u. Bewegung)
Title:A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Indication:Breast Neoplasms
Type of study:Phase II/III
Contact: Charlotte Kreutz (Kontaktperson)
[charlotte.kreutz@nct-heidelberg.de]
Investigator: Dr. Martina Schmidt (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02999074
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Mamma-Studie

(neoadjuvant, epidemiologisch)
Title:Kardiotoxitizität (neo)adjuvanter Chemotherapie bei Patienten mit Mamma-Karzinom
Indication:Mamma-Karzinom
Type of study:Phase N/A
Contact: Ines Ludwig (Kontaktperson)
[Ines.Ludwig@med.uni-heidelberg.de]
Investigator: Dr. med. Lorenz Lehmann (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

NCT-PMO-1603 TOP-ART

(second-line, BRCAness)
Title:A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies
Indication:Krebs mit DNA-Reparatur-Defizite
Type of study:Phase II
Contact: Barbara Stöhr (Study Nurse)
[barbara.stoehr@nct-heidelberg.de]
Investigator: Prof. Dr. Stefan Fröhling (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03127215
EudraCT: 2017-001755-31 (siehe EU klinisches Studienregister)

PRAEGNANT (SEN-01/14)

(Biomarker)
Title:Prospective Academic Translational Research Network for the Optimization of the Oncological Health Care Quality in the Adjuvant and Advanced/Metastatic Setting: Health Care Research, Pharmacogenomics, Biomarkers, Health Economics
Indication:Breast Neoplasms
Type of study:Phase N/A
Contact: Christian Lange (Kontaktperson)
[christian.lange@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02338167
EudraCT: 2014-000854-12 (siehe EU klinisches Studienregister)

Kurative DWI-MRM (Folge Studie SBT)

(diagnostisch, Screening)
Title:Diffusionsgewichtete MRT (DWI) in der Abklärung klinisch und mammographisch suspekter Befunde der weiblichen Brust
Indication:Früherkennung
Type of study:Phase N/A
Contact: Radiologie, DKFZ (E10) (Kontaktperson)
[-]
Investigator: Prof. Dr. Heinz-Peter Schlemmer (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

DARPI MP0274-CP101

(metastasiert, HER2-positiv)
Title:A Phase 1, First-in-human, Single-arm, Multi-center, Open-label, Repeated-Dose, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MP0274 in Patients With Advanced HER2-positive Solid Tumors
Indication:Patients with HER2-positive solid tumors that is unresectable, locally advanced, or metastatic with progression
Type of study:Phase I
Contact: Christiane Dobeleit (Study Nurse)
[Christiane.Dobeleit@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03084926
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

AIPAC

Title:AIPAC (Active Immunotherapy PAClitaxel): A multicentre, Phase IIb, randomised, double blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel.
Indication:Metastatic breast cancer
Type of study:Phase II
Contact: Franziska Machts-Kauker (Study Nurse)
[fransziska.machts@med.uni-heidelberg.de]
Investigator: Prof. Dr. Frederik Marmé (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02614833
EudraCT: 2015-002541-63 (siehe EU klinisches Studienregister)

BCP (GBG 29)

Title:Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy
Indication:Breast Neoplasms
Type of study:Phase II
Contact: Werner Diehl (Kontaktperson)
[werner.diehl@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT00196833
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

CATCH

Title:Comprehensive assessment of clinical features and biomarkers to identify patients with advanced or metastatic breast cancer for marker driven trials in humans (CATCH).
Indication:Breastcancer
Type of study:Phase N/A
Contact: Martina Haselmayr (Study Nurse)
[martina.haselmayr@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

COGNIFiT

Title:Cognitive Function in patients with gynecological Tumors.
Indication:Diagnose Brustkrebs oder gynäkologischer Tumor
Type of study:Phase N/A
Contact: Dr. Martina Schmidt (Kontaktperson)
[m.schmidt@dkfz.de]
Investigator: Prof. Dr. Karen Steindorf (Prüfer)
Trial Register: Die Studie ist beim "DRKS - Deutsches Register Klinischer Studien" registriert. Siehe DRKS00015757
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

DETECT V / CHEVENDO

Title:DETECT V / CHEVENDO CHemo- Versus ENDOcrine Therapy in Combination With Dual HER2-targeted Therapy of Herceptin® (Trastuzumab) and Perjeta® (Pertuzumab) in Patients With HER2 Positive and Hormone-receptor Positive Metastatic Breast Cancer
Indication:Breast Neoplasms
Type of study:Phase III
Contact: Christiane Dobeleit (Study Nurse)
[Christiane.Dobeleit@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02344472
EudraCT: 2014-002249-22 (siehe EU klinisches Studienregister)

GeparDouze/NSABP_B-59/GBG96

Title:Randomisierte, doppelblinde Phase III Studie zur Untersuchung von Atezolizumab oder Placebo in Kombination mit einer neoadjuvanten Chemotherapie gefolgt von einer adjuvanten Monotherapie mit Atezolizumab oder Placebo bei triple- negativem Brustkrebs (GeparDouze)
Indication:Patienten mit primärem Brustkrebs
Type of study:Phase III
Contact: Tina Bausewein (Study Nurse)
[tina.bausewein@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03281954
EudraCT: 2017-002771-25 (siehe EU klinisches Studienregister)

Impassion 131 (MO39196)

Title:A PHASE III, MULTICENTER, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH PACLITAXEL COMPARED WITH PLACEBO WITH PACLITAXEL FOR PATIENTS WITH PREVIOUSLY UNTREATED INOPERABLE LOCALLY ADVANCED OR METASTATIC TRIPLE NEGATIVE BREAST CANCER
Indication:Triple negative breast cancer
Type of study:Phase III
Contact: Andrea Kohl (Study Nurse)
[andrea.kohl@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-004024-29 (siehe EU klinisches Studienregister)

Impassion 132 (MO39193)

Title:A PHASE III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF ATEZOLIZUMAB PLUS CHEMOTHERAPY FOR PATIENTS WITH EARLY RELAPSING RECURRENT (INOPERABLE LOCALLY ADVANCED OR METASTATIC) TRIPLE-NEGATIVE BREAST CANCER
Indication:Triple-Negative Breast Cancer (TNBC)
Type of study:Phase III
Contact: Andrea Kohl (Study Nurse)
[andrea.kohl@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Florian Schütz (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-005119-42 (siehe EU klinisches Studienregister)

Kardio- Studie

Title:Prädiktoren kardio-vaskulärer Funktionseinschränkungen bei Krebskranken
Indication:Brustkrebs
Type of study:Phase N/A
Contact: Radiologie, DKFZ (E10) (Kontaktperson)
[-]
Investigator: Prof. Dr. Heinz-Peter Schlemmer (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

MERIT

Title:First-in-human Clinical Study With RNA-Immunotherapy Combination of IVAC_W_bre1_uID and IVAC_M_uID for Individualized Tumour Therapy in Triple Negative Breast Cancer Patients
Indication:Breast Neoplasms, Triple Negative Breast Neoplasms
Type of study:Phase I
Contact: Bettina Kammer (Study Nurse)
[bettina.kammer@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02316457
EudraCT: 2014-002274-37 (siehe EU klinisches Studienregister)