Planned
DECRESCENDO - EORTC 1965
De-Escalation of adjuvant ChemotheRapy in HER2-positive, EStrogen reCEptor-negative, Node-negative early breast cancer patients who achieved pathological complete response after neoadjuvant chemotherapy and Dual HER2 blOckade
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04675827
ExpandiT
A neoadjuvant study evaluating T cell clonotype expansion as a mechanism of response to a sacituzumab govitecan- and pembrolizumab based regimen in early triple-negative breast cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
Ongoing
ASCENT 03 GS-US-592-6238
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan in TNBC with no PDL1 tumor expression or previously treated with anti-PD-L1
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
ASCENT 04 GS-US-592-6173
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced,Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
BrainStorm - IJB-BS-ODN-006
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04109131
DESTINY-05 - DS8201-A-U305
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04622319
DESTINY-08 - D967JC00002
A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04556773
DESTINY-09 - D967UC00001
Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04784715
DESTINY-12 - D9673C00007
An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04739761
IMPASSION 030 WO39391
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03498716
IMMU-132-14
Open-label Rollover Study to Evaluate Long-Term Safety in Subjects with Metastatic Solid Tumors that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04319198
TNBC ZEN003694-004
Phase 2 Study of ZEN003694 in Combination with Talazoparib in Patients with Triple-Negative Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03901469
Closed
APPALACHES EORTC 1745-ETF-BCG
A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03609047
ASCENT IMMU-132-05
Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT02574455
AURORA BIG 14-01 / EORTC 1408
Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT02102165
B-PRECISE-01 MEN1611-01
A multicenter phase Ib study that will evaluate the safety and efficacy of MEN1611 plus trastuzumab with or without fulvestrant
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03767335
BROCADE M12-914
A phase III, randomized, placebo-controlled trial of carboplatin and paclitaxel with or without the PARP inhibitor veliparib (ABT-888) in HER2-negative metastatic or locally advanced unresectable BRCA-associated breast cancer
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT02163694
BYON5667.002
A multicenter, randomized, double-blind, placebo-controlled trial with a single arm run-in period to evaluate the safety and efficacy of sodium thiosulfate (BYON5667) eye drops to reduce ocular toxicity in cancer patients treated with SYD985
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04983238
CONTESSA TRIO ODO-TE-B202
A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03952325
CONTESSA ODO-TE-B301
Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxan
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03326674
DESTINY 01 DS8201-A-U201
A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03248492
DESTINY 02 DS8201-A-U301
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03523585
DESTINY 03 DS8201-A-U302
Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03529110
DESTINY 04 DS8201-A-U303
A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03734029
DESTINY-06 - D9670C00001
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04494425
ELDERLY EORTC 75111-10114
Pertuzumab + Trastuzumab (PH) Versus PH Plus Metronomic Chemotherapy (PHM) in the Elderly HER2+ Metastatic Breast Cancer Population Who May Continue on T-DM1 Alone Following Disease Progression While on PH / PHM: an Open-label Multicentre Randomized Phase II Selection Trial of the EORTC Elderly Task Force and Breast Cancer Group
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT01597414
EPIK-B2 CBYL719G12301
A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04208178
FEDERICA WO40324
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03493854
HER2CLIMB-02 - SGNTUC-016
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03975647
I3Y-MC-JPCE
A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer
- Principal investigator : Prof. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT02779751
IMPASSION 031 WO39392
A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03197935
IMPASSION 130 WO29522
A phase III, multicenter, randomized, placebo-controlled study of MPDL3280A (anti-PD-L1 antibody) in combination with NAB-paclitaxel compared with placebo with NAB-paclitaxel for patients with previously untreated metastatic triple-negative breast cancer
- Principal investigator : Prof. B. Beuselinck
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT02425891
INTR@PID Breast 020 - MS200647-0020
A Phase II, Multicenter, Open Label Study of Bintrafusp alfa (M7824) Monotherapy in Participants with HMGA2-expressing Triple Negative Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04489940
IPATunity 130 CO40016
A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03337724
KEYNOTE-756 MK3475-756
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03725059
MERUS MCLA-128-CL02
Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC NCT03321981
- Principal investigator : Prof. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03321981
PERUSE MO28047
A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
- Principal investigator : Prof. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT01572038
RIBOB
A phase IV Study to collect data on the efficacy and safety of RIBociclib in combination with letrozole in Older women (≥70 years) with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced Breast cancer (aBC) with no prior systemic therapy for advanced disease)
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03956654
SUMMIT PUMA-NER-5201
An open-label, phase 2 study of Neratinib in patients with solid tumors with somatic human epidermal growth factor receptor (EGFR, HER2, HER3) mutations or EGFR gene amplification
- Principal investigator : Prof. Dr. Hans Wildiers
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT01953926
TENACITY AL-TNBC-01
A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT04461600
TROPICS-02 IMMU-132-09
Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03901339
TROPION Breast 01 - D9268C00001
Phase 3, Open Label, Randomized Study of Datopotamab Deruxtecan (Dato-DXd) versus Investigator’s Choice Chemotherapy in inoperable or Metastatic Hormone Receptor-positive, HER2-negative, Breast Cancer patients who have been treated with one or two lines of systemic chemotherapy in the metastatic setting
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT05104866
TULIP SYD985.002
A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03262935
VIOLETTE D5336C00001
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy
- Principal investigator : Dr. Kevin Punie
- Back-up principal investigator : Prof. Dr. Patrick Schöffski
- More information : NCT03330847
Other
Clinical Studies Multidisciplinary Breast Center (MBC)
The multidisciplinary breast center (MBC) focuses on the diagnosis and treatment of all problems with your breasts, both benign breast conditions and breast cancer.
- More information : Overview of Studies