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A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer.

The main purpose of this study is to determine the side effects of trastuzumab when it is given by each of these subcutaneous injection methods. The study will also gather information about whether and when the cancer comes back after taking…

A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment

Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…

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 phase II prospective imaging study evaluating the utility of pre-treatment zirconium-89 labelled trastuzumab PET/CT and an early FDG-PET/CT response to identify patients with advanced HER-2 positive breast cancer unlikely to benefit from a novel anti-HER2 therapy: T-DM1

The primary objective (on lesion-based analysis) is to show that pre-treatment 89Zr-trastuzumab PET/CT is able to select lesions not responding morphologically from treatment with T-DM1 (applying RECIST 1.0 criteria)Secondary Objectives and…

The effects of a yoga-based stress reduction program on fatigue and quality of life in women with chemotherapy for breast cancer: a mono-centre, pragmatic, randomized clinical study

To investigate whether an adjunctive YBSR program added to standard care compared to standard care alone, can reduce:1.fatigue symptoms (primary objective)2.psychological distressand improve:3.health-related quality of life4.sense of coherence5.…

Change of body composition in breast cancer: All-in Assessment

The aims of this project are to:1. Assess what percentage of breast cancer patients experience accelerated gain in fat mass, loss of muscle mass and muscle strength as induced during chemotherapy2. Assess whether changes in energy intake, protein…

Axillary lymph node dissection without drain AND with the LigaSure Precise instrument (ANDPrecise)

The AND PRECISE PROTOCOL aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not…

Sentinel Node Biopsy using Magnetic Nanoparticles: A prospective multicentre phase II non-randomised clinical trial to compare sentinel node biopsy using magnetic nanoparticles vs.
standard technique

The principal objective of the study is to determine if the performance of the new technique (magnetic tracer and magnetometer) is equivalent to the performance of the standard technique (patent blue dye and radioisotope; or radioisotope alone).The…

Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)

Primary objective:To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC). Secondary objectives:To determine if occurrence of docetaxel toxicity can be related to dose/LBM.To…

A multicenter, randomized, double blind, placebo controlled, phase II trial evaluating the safety and efficacy of TKI258 combined with fulvestrant, in postmenopausal patients with HER2- and HR+ breast cancer that have evidence of disease progression on or after prior endocrine therapy

Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…

Clinical and pharmacological feasibility study with 2B3-101 in patients with breast cancer
and leptomeningeal metastases

Primary: To determine the response of 2B3-101 treatment as single agent or in combination with trastuzumab in patients with LM from breast cancer using the LM response scoreSecundary: - To determine the safety profile in patients with LM treated…

A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment (CBKM120F2302)

Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…

Clinical evaluation of dried blood spots for the determination of tamoxifen and endoxifen levels

Clinical evaluation of dried blood spot (DBS) assay, by determining the ratio between DBS and serum levels of tamoxifen and endoxifen and to investigate if patients can obtain useful DBS at home.

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.

Ovarian hyperstimulation in women with estrogen-receptor positive breastcancer who opt for embryo- or oocyte freezing: Is the Tamoxifen dosage sufficient to protect women against estrogen exposure? (TAMOXI project: a pilot study).

The objective of this pilot-study is to investigate if the current dosage of tamoxifen supplied to women with estrogen receptor positive breastcancer who opt for embryo- or oocyte freezing is protective during the whole period of hormone stimulation…

A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.

Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…

MRI-guided High-Intensity Focused Ultrasound Ablation of Breast Cancer

The main objective of this feasibility study is to assess the treatment accuracy of MR-HIFU in patients with breast cancer using a dedicated MR-HIFU breast system. A secondary objective is to determine the safety.

Early monitoring of trastuzumab +/- pertuzumab therapy with 18F-choline PET/CT in patients with advanced disease breastcancer.

In this pilotstudy we are planning to investigate in a relatively low number of patients if [18F]-choline uptake will decrease after 2 to 3 weeks of trastuzumab +/- pertuzumab therapy in morphologically responding patients (as noted after 12 weeks…

Towards plannable breast surgery: diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node (MIB study)

Research question: Is microbubble-enhanced Iodine-125 seed localization an accurate tool for preoperative identification of the sentinel lymph node in women with breast cancer, in terms of diagnostic accuracy, sensitivity, feasibility, patient…

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…