Search for a trial

Non-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset.

The aim of this pilot-study is to examine the accuracy of MRL compared to current nodal staging methods. We expect anacceptable accuracy of the MRL based on earlier studies with gadofosveset enhanced MRI in rectum cancer patients. Then the MRL could…

A multicenter, single arm study of trastuzumab emtansine (T-DM1) in HER2 positive locally advanced or metastatic breast cancer patients who have received prior anti-HER2 and chemotherapy-based treatment

The primary objective of this study is to evaluate the safety and tolerability of trastuzumab emtansine.

An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI

To assess the effectivity and safety of 1.0 molar gadobutrol (Gadovist®) for breast MRI

An open-label, multi-center, expanded access study for postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer who have progressed following prior endocrine therapy, investigating the treatment of everolimus (RAD001) in combination with exemestane

Primary objective: to evaluate safety of everolimus in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer that is refractory to NSAIs.Secondary objective: to evaluate adverse events grade 3 and 4 in the…

Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery.

This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and Patent Blue) in detecting…

An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor- positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease (COMPLEEMENT-1, CLEE011A2404)

Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…

Can molecular imaging predict outcome to firstline endocrine treatment ± CDK 4/6 inhibition in
advanced ER+ breast cancer?

Based on the data as described above, we hypothesize that the FES-PET heterogeneity score can predict progression free survival (PFS) in individual patients prior to start of 1st line endocrine treatment and CDK 4/6 inhibition in ER+ advanced breast…

Selecting the Optimal position of CDK4/6 Inhibitors in HR+ Advanced breast cancer: the SONIA trial

This study has been transitioned to CTIS with ID 2024-516204-42-00 check the CTIS register for the current data. The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition…

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 (DESTINY-Breast12)

Primary objective:To describe the overall treatment effect of T DXd in HER2+ MBC patients with or without baseline brain metastasisSecondary objectives:- To describe the treatment effect on the development and progression of brain metastasis in…

PALbociclib CoLlaborative Adjuvant Study:
A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer

This study has been transitioned to CTIS with ID 2024-514841-12-00 check the CTIS register for the current data. Primary Objective:To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year…

HOMERUS: A LOCAL, OPEN LABEL, MULTICENTRE, PHASE IIIB STUDY, INVESTIGATING SUBCUTANEOUS TRASTUZUMAB ADMINISTERED AT HOME WITH SINGLE INJECTION DEVICE IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER

The primary objective of this study is to assess the overall safety and tolerability of subcutaneous (SC) trastuzumab using SID (Singel Injection Device) in HER2-positive eBC (early Breast Cancer) patients self-administered at home under supervision…