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: 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. Juliane Hörner-Rieber (Kontaktperson)
[Juliane.Hoerner-Rieber@med.uni-heidelberg.de]
Investigator: Dr. med. Juliane Hörner-Rieber (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.

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: 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.

IMagyn050 (Ovar 22) 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: Prof. Dr. 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)

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: 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.

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: Prof. Dr. 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)

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.

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. Juliane Hörner-Rieber (Kontaktperson)
[Juliane.Hoerner-Rieber@med.uni-heidelberg.de]
Investigator: Dr. med. Juliane Hörner-Rieber (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)

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: Christiane Dobeleit (Study Nurse)
[c.dobeleit@dkfz-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
Contact: Franziska Machts-Kauker (Study Nurse)
[fransziska.machts@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.

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)
[c.dobeleit@dkfz-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: Sabine Wagner (Study Nurse)
[Sabine.Wagner@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: Sabine Wagner (Study Nurse)
[Sabine.Wagner@med.uni-heidelberg.de]
Investigator: PD Dr. med. Florian Schütz (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-005119-42 (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: Teresa Töpfer (Kontaktperson)
[teresa.toepfer@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)

NeoTRIPaPDL1

Title:Neo-Adjuvant Study With the PDL1-directed Antibody in Triple Negative Locally Advanced Breast Cancer Undergoing Treatment With Nab-paclitaxel and Carboplatin
Indication:Women with triple negative, early invasive unilateral breast cancer and suitable for neoadjuvant therapy
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 NCT02620280
EudraCT: 2014-005017-23 (siehe EU klinisches Studienregister)

PHERGain/ MedOPP096-MO39229

Title:Chemotherapy-free trastuzumab and pertuzumab in HER2-positive breast cancer: FDG-PET response-adapted strategy. The PHERGain study
Indication:HER2-positive breast cancer
Type of study:Phase II
Contact: Bettina Kammer (Study Nurse)
[bettina.kammer@med.uni-heidelberg.de]
Investigator: Prof. Dr. Frederik Marmé (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-002676-27 (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: Eileen Kurre (Study Nurse)
[eileen.kurre@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)

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)