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Radiowave radar imaging for breast cancer detection * a feasibility study

Our study aim is to assess whether MARIA* can provide diagnostic information that can supplement, and in some cases, replace mammography as a tool in the symptomatic workflow. We will also seek patient feedback on this non-ionising, non-compressing…

FES (16α-[18F]-fluoro-17β-estradiol)-PET: Towards a new standard for staging of clinical stage II/III and recurrent, estrogen receptor positive (ER+) breast cancer? Pilot study to compare [18F]FES-PET and [18F]FDG-PET.

To determine whether [18F]FES PET/CT improves staging for women with clinical stage II/III or LRR, ER+ breast cancer as compared to standard [18F]FDG PET/CT.

Therapeutic Drug Monitoring guided tamoxifen dosing: a feasibility study in patients with hormone positive breast cancer

Primary Objective1. To prove that TDM of tamoxifen is feasible in clinical practice. Secondary Objectives1. To determine the relation between the pharmacokinetics (PK) of tamoxifen and its metabolites and relevant adverse effects.2. To investigate…

Rapid Access to Contrast-Enhanced spectral mammogRaphy (RACER): a more efficient work-up of women recalled from breast cancer screening

The RACER project studies a more efficient approach based on (rapid access to) CESM, primarily resulting in less follow-up exams due to the superior specificity of CESM over FFDM. In addition, otherwise occult cancers will be detected in the women…

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 Alone and in Combination with Palbociclib in Women with Estrogen Receptor Positive, HER2-Negative Advanced Breast Cancer

The primary objective of the study are to: 1) Determine the safety and tolerability of G1T48 alone (Parts 1 and 2) or in combination with palbociclib (Part 3), 2) Determine the MTD and RP2D of G1T48 alone (Parts 1 and 2) or in combination with…

Image-guided targeted doxorubicin delivery with hyperthermia to optimize loco-regional control in breast cancer; the i-GO feasibility study. Phase I Feasibility Study of High-Intensity Focused Ultrasound-Induced Hyperthermia, Lyso-Thermosensitive Liposomal Doxotubicin for Metastatic Breast Cancer

The primary objective is to determine the safety, tolerability and feasibility of pre-surgical lyso-thermosensitive liposomal doxorubicin (ThermoDox) + MR-HIFU induced local hyperthermia therapy in metastatic breast cancer. The secondary objectives…

The representation of the breast on the somatosensory cortex after autologous breast reconstruction using 7 Tesla functional MRI

To study the neuroplasticity of the brain after mastectomy and breast reconstructive surgery by assessing the somatotopy of the breast on the somatosensory cortex of patients who underwent either breast reconstruction with and without nerve…

Towards OPtimal TIming and Method for promoting sUstained adherence to lifestyle and body weight recommendations in postmenopausal breast cancer survivors: the OPTIMUM-study.

The OPTIMUM-study aims to gain insight into the optimal timing and method for promoting sustained adherence to lifestyle and body weight recommendations in PMBC survivors.The aim of the extra measurement during the second COVID-19 lockdown is to…

Geometric accuracy of accelerated partial breast irradiation on the Cyberknife using standard surgical clips as a fiducial marker

The primary objective is to prospectively quantify the geometric uncertainty of CK-APBI and to propose a validated PTV margin.Secondary objectives are: - To evaluate the success rate of using surgical clips as fiducial markers- To evaluate the…

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the
Safety and Efficacy of Agents Targeting DNA Damage Repair in
Combination with Olaparib versus Olaparib Monotherapy in the Treatment
of Metastatic Triple Negative Breast Cancer Patients Stratified by
Alterations in Homologous Recombinant Repair (HRR)-related Genes
(including BRCA1/2)

Olaparib + AZD1775 - this treatment arm was closed.Study objectives are defined for the following patient populations:* *Breast cancer susceptible gene mutation (BRCAm)* = patients from stratum A· *Homologous Recombination Repair gene mutation (HRRm…

Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients: a follow-up study of two previous randomized controlled trials.

To investigate if participation in a moderate to high-intensity exercise program during adjuvant chemotherapy has reduced cardiovascular toxicity in women with breast cancer after an average follow-up of 6 years.

A randomised, double-blind, parallel group, equivalence, multicentre phase III trial to compare the efficacy, safety and pharmacokinetics of HD201 to
Herceptin® in patients with HER2+ early breast cancer.

The primary objective of this study is to show equivalence of the total pathological complete response rate (tpCR) in patients treated withHD201 plus chemotherapy to that in patients treated with Herceptin® plus chemotherapy. tpCR will be assessed…

MRI-guided single dose preoperative radiotherapy in low-risk breast cancer

The goal of this study is to assess the efficacy of single dose preoperative radiotherapy in patients with low risk breast cancer. In this context, efficacy is the proportion of patients achieving a pathologic complete response after single dose…

Non-invasive screening of the breast with the DELSENI with the DMS method.

The objective of this study is the determination of the diagnostic quality (sensitivity, specificity, positive predictive value, negative predictive value) for the detection of malignant or pre-malignant tumor with the DELSENI in comparison with…

Effect of the moderate CYP3A4-inhibitor erythromycin on the pharmacokinetics of palbociclib

The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…

A radiopaque hydrogel to improve target definition of boost or partial breast irradiation in patients with low cavity visualization scores

Primary objective: Estimate the added value of using hydrogel in addition to clips only in terms of the Conformity Index (Cx) of tumorbed delineationSecondary objectives: Estimate the Cavity Visualisation Score (CVS), distance between the center of…