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. David Krug (Kontaktperson)
[david.krug@med.uni-heidelberg.de]
Investigator: Dr. med. Nathalie Arians (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.

Hyposib

(adjuvant)
Title:Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation
Indication:Breast Neoplasms
Type of study:Phase
Contact: Dr. med. Nathalie Arians (Kontaktperson)
[nathalie.arians@med.uni-heidelberg.de]
Investigator: David Krug (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02474641
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

HIPOvar-Studie:

(Biomarker)
Title:Identification of novel subtype specific alterations as candidates for drug targets and characterization of intratumour genetic heterogeneity and its contribution to therapy resistance in high grade serous ovarian carcinoma (HGSOC)
Indication:Ovarial CA bei Erstdiagnose
Type of study:Phase N/A
Contact: Maunela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Dr. med. Frederik Marmé (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 I "Chemotherapie"

(diagnostisch, Früherkennung, Screening)
Title:Chemotherapie-induzierte Veränderungen in der diffusionsgewichteten MRT (DWI) bei Patientinnen mit Ovarialkarzinomen
Indication:ovary cancer
Type of study:Phase N/A
Contact: Radiologie DKFZ (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:ovary cancer
Type of study:Phase N/A
Contact: Radiologie DKFZ (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:ovary cancer
Type of study:Phase N/A
Contact: Radiologie DKFZ (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: Maunela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Dr. med. 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.

Nov RAFi (CLXH254X2101)

Title:A Phase I Dose Finding Study of Oral LXH254 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations
Indication:-
Type of study:Phase I
Contact: Bettina Mutz (Study Nurse)
[bettina.mutz@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 NCT02607813
EudraCT: 2015-003421-33 (siehe EU klinisches Studienregister)

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: Maunela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Dr. med. 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.

PALEO

Title:ENGOT-EN3-NSGO/PALEO: A Randomized, Double-blind, Placebo-controlled, Phase II Trial of Palbociclib in Combination With Letrozole Versus Placebo in Combination With Letrozole for Patients With Estrogen Receptor Positive Advanced or Recurrent Endometrial Cancer.
Indication:Endometrial Neoplasms
Type of study:Phase II
Contact: Maunela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Dr. med. Frederik Marmé (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02730429
EudraCT: 2016-001848-20 (siehe EU klinisches Studienregister)

PRIMA PR-30-5017-C

Title:A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Indication:Ovarian Neoplasms
Type of study:Phase III
Contact: Maunela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Dr. med. Frederik Marmé (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02655016
EudraCT: 2015-000952-11 (siehe EU klinisches Studienregister)

YO39523

Title:A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (IMagyn050)
Indication:Fallopian Tube NeoplasmsPeritoneal Neoplasms
Type of study:Phase III
Contact: Maunela Reining (Study Nurse)
[manuela.reining@med.uni-heidelberg.de]
Investigator: Dr. med. Frederik Marmé (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03038100
EudraCT: 2016-003472-52 (siehe EU klinisches Studienregister)

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: Prof. Dr. med. Andreas Schneeweiss (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.

Hyposib

(adjuvant)
Title:Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation
Indication:Breast Neoplasms
Type of study:Phase
Contact: Dr. med. Nathalie Arians (Kontaktperson)
[nathalie.arians@med.uni-heidelberg.de]
Investigator: David Krug (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02474641
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 Chemotheraopiue beu Patienten mit Mamma-Karzinom
Indication:Mamma-Karzinom
Type of study:Phase N/A
Contact: Ines Ludwig (Kontaktperson)
[Ines.Ludwig@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Oliver Müller (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.

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:breast cancer
Type of study:Phase N/A
Contact: Radiologie DKFZ (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

(metastatsiert, 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: Daniela Höyer (Study Nurse)
[daniela.hoeyer@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.

TOP-Studie

(supportive care trial, Sport u. Bewegung)
Title:Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study
Indication:-
Type of study:Phase II/III
Contact: Kathrin Schlüter (Kontaktperson)
[kathrin.schlueter@nct-heidelberg.de]
Investigator: Dr. Joachim Wiskemann (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02883699
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

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: Bettina Kammer (Kontaktperson)
[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 NCT00196833
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: Martina Haselmayr (Kontaktperson)
[martina.haselmayr@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: 2014-002249-2 (siehe EU klinisches Studienregister)

Insema (GBG 75)

Title:Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Patients With Early-stage Invasive Breast Cancer and Breast-conserving Surgery: a Randomized Prospective Surgical Trial. Intergroup-Sentinel-Mamma (INSEMA)-Trial
Indication:Breast Neoplasms
Type of study:Phase N/A
Contact: Prof. Dr. med. Andreas Schneeweiss (Kontaktperson)
[andreas.schneeweiss@med.uni-heidelberg.de]
Investigator: Dr. med. Jörg Heil (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02466737
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)

Nov RAFi (CLXH254X2101)

Title:A Phase I Dose Finding Study of Oral LXH254 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations
Indication:-
Type of study:Phase I
Contact: Bettina Mutz (Study Nurse)
[bettina.mutz@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 NCT02607813
EudraCT: 2015-003421-33 (siehe EU klinisches Studienregister)

Ribecca-Studie (CLEE011XDE01)

Title:A national phase IIIb, multi-center, open label study for women with hormone-receptor positive locally advances or metastasic breast cancer treated wirh ribociclib (LEE011) in combination with letrozole
Indication:mamma carcinoma
Type of study:Phase III
Contact: Daniela Höyer (Study Nurse)
[daniela.hoeyer@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Andreas Schneeweiss (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-002556-24 (siehe EU klinisches Studienregister)

SOPHIA CP-MGAH22-04

Title:A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment
Indication:Breast NeoplasmsNeoplasm Metastasis
Type of study:Phase III
Contact: Martina Haselmayr (Study Nurse)
[martina.haselmayr@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 NCT02492711
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Seraphina

Title:Safety, Efficacy and Patient Reported Outcomes of Advanced Breast Cancer Patients: Therapy Management With Nab-Paclitaxel in Daily Routine - SERAPHINA
Indication:Metastatic Breast Cancer
Type of study:Phase IV
Contact: Christian Lange (Study Nurse)
[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 NCT02642406
EudraCT: 2015-001337-25 (siehe EU klinisches Studienregister)