Search for a trial

Optimizing accelerometer data analysis to assess physical activity and sedentary behavior among breast cancer survivors: a laboratory study

1. To validate accelerometer cut-points to asses physical activity and sedentary behavior of breast cancer survivors. 2. To investigate the validity of accelerometers, inclinometers, heart rate and oxygen consumption to assess time spent in…

Non-invasive monitoring of breast cancer therapy using circulating tumor DNA from peripheral blood

The primary objective of this clinical study is to identify whether activating mutations in ESR1 detected in circulating tumor DNA (ctDNA) in peripheral blood are associated with resistance to endocrine therapy in patients with ER-positive, human…

The effect of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with breast cancer *the ELDORADO study*

The main objective is: To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).Secundary objectives are:1. Other pharmacokinetic outcomes (i.e. clearance, minimum…

Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 lesions: Can patient selection for biopsy be improved? - A confirmatory Multi-Center-Study

The main objective of this study is to improve the power of breast ultrasound examinations by evaluating tissue alterations by means of Elastography. Recent studies have shown that there is a correlation between stiffness and malignancy of tissue.…

BReast cancer Ex vivo Anthracycline Sensitivity Test (BREAST) study;Using ex vivo drug sensitivity tests to optimize breast cancer therapy in the future

To determine the concordance between the ex vivo anthracycline sensitivity test and in vivo response to anthracycline-based NAC. Also, optimal cut-off values for the ex vivo anthracycline sensitivity assay are determined to carefully predict in vivo…

Minimal invasive breast cancer excision using the breast lesion excision system under ultrasound guidance - a feasibility study

Our study aim is to assess whether it is feasible to remove small breast cancers completely using the BLES system under US guidance.

Supine MRI-guided navigation for tumor localization in breast cancer patients: a feasibility study.

Primary goal: to assess the accuracy of a supine magnetic resonance imaging (MRI)-guided electromagnetic navigation system used for tumor marker implantation in breast cancer patients.Secondary goal: to assess the variability in target volume…

A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy

Primary objectiveTo assess the risk of breast cancer relapse associated with temporaryinterruption of endocrine therapy (ET) to permit pregnancy.Secondary objectiveTo evaluate factors associated with pregnancy success after interruption ofendocrine…

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…

Dedicated Breast CT for Diagnosis of Breast Cancer.

We propose to perform a prospective trial to compare the accuracy of breast CT to the current standard imaging technologies for diagnosis of breast cancer in patients with a suspicious lesion identified during breast cancer screening.

Tailored treatment in Older Patients
TOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer

The main focus of the present proposal is a first step towards treatment intensity de-escalation in older breast cancer patients. For this, we propose to initiate the first TOP consortium study (TOP-1) that will study the effect of omitting…

Pre- versus Postoperative Accelerated Partial Breast Irradiation in early stage breast cancer patients

To assess the cosmetic effect of preoperative versus postoperative partial breast irradiation (prePBI vs postPBI)

Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy (SUBITO) an international randomized phase III trial

This study has been transitioned to CTIS with ID 2024-516196-32-00 check the CTIS register for the current data. To investigate whether (neo)adjuvant systemic treatment of intensified alkylating chemotherapy with peripheral stem cell rescue (mini-…

Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer

To investigate the effect of a 6-month exercise programme on cognitive problems in chemotherapy-exposed breast cancer patients who have cognitive problems (both on the self-report level and by formal assessment). Furthermore, we are specifically…

Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CPDR001X2102)

Primary: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus, HDM201, QBM076 or panobinostat and to identify recommended doses and schedules for future studies.Secondary: To characterize changes in the immune…

A feasibility study of niraparib for advanced, BRCA1-like, HER2-negative breast cancer patients: the ABC study

To establish whether niraparib single agent treatment in advanced BRCA1-like, HER2 negative breast cancer patients deserves to be further studied

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastatic Setting (NALA)

Primary: The co-primary objectives of this study are* to compare independently adjudicated progression-free survival (PFS) following treatment with neratinib pluscapecitabine versus lapatinib plus capecitabine in patients with HER2-positive (HER2+)…

Primary Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with Sentinel node procedure (RISAS) following neoadjuvant chemotherapy (NAC): a novel surgical approach to accurately assess axillary response to neoadjuvant systemic therapy, thereby reducing future need for completion axillary lymph node dissection and subsequent morbidity

The main goal of this study is to examine the accuracy (identification rate of the MARI-node and Sentinel node, sensitivity, negative predictive value (NPV) and false-negative rate (FNR)) of the RISAS procedure compared to the current standard…

Early diagnosis of breast cancer:
A multicenter, crOss sectional, study to assess microRNA expression in Nipple Aspirate Fluid, blood and tuMor material in women with primary brEast caNcer compared with healthy conTrols
The ORNAMENT study

The validation of microRNA expression for screening and prevention of breast cancer

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer * (KEYNOTE-355)

The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) in combination with chemotherapy drugs of physician's choice (which includes Nab-paclitaxel, Paclitaxel or…