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Algemene medische oncologie

Klinische studies borsttumoren

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Planned

DESTINY 15 - DS8201-0001-CIS-MA 

A Phase 3b, Multicenter, Global, Interventional, Open-label, Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer

OPT-PEMBRO

OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab

PCS6422 

Phase 2, open-label, randomized, multi-center study of PCS6422 (study drug) with capecitabine (Cap) in patients with advanced or metastatic breast cancer

PIKture-01   OKI-219-101 

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants with Advanced Solid Tumors and in Combination with Endocrine Therapy or HER2-Targeted Therapy in Participants with Advanced Breast Cancer

Ongoing

AURORA BIG 14-01 / EORTC 1408

Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer

BrainStorm - IJB-BS-ODN-006

A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours

Dynasty-Breast 02 - DB-1303-O-3002

Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)

TROPION 04 - D926QC00001

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtemab (Dato Dxd) Plus Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients with Untreated Triple-Negative or Hormone Receptor low/HER2-negative Breast Cancer

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

ASCENT IMMU-132-05

Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer

ASCENT03 - 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

ASCENT04 - 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

ASCENT 07 - GS-US-598-6168

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

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

BROCADE M12-9142

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 : Prof. Hans Wildiers
  • Sponsor : Hoffmann-La Roche
  • More information : NCT03197935
  • Indication : 
  • Internal reference number : s60397

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
  • Sponsor : Hoffmann-La Roche
  • More information : NCT02425891
  • Indication : 
  • Internal reference number : s57792

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

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 : Prof. Hans Wildiers
  • Sponsor : Hoffmann-La Roche
  • More information : NCT03337724
  • Indication : 
  • Internal reference number : s60653

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

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

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
  • Sponsor : Hoffmann-La-Roche
  • More information : NCT01572038
  • Indication : 
  • Internal reference number : s53820

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)

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

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

TNBC ZEN003694-004

 Phase 2 Study of ZEN003694 in Combination with Talazoparib in Patients with Triple-Negative Breast Cancer

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

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

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

VIOLETTE D5336C00001

To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy

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.

Laatste aanpassing: 23 oktober 2024