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Breast cancer with low risk of recurrence:partial and accelerated radiation with three dimensional conformal radiotherapy (3DCRT) vs standard radiotherapy after conserving surgery (phase III study)

The study proposes to evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer with low risk of local recurrence and who undergo conservative surgery, is not inferior…

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…

A randomized study of an internet-based cognitive behavioral therapy program for sexuality and intimacy problems in women treated for breast cancer.

The proposed study will evaluate the efficacy of an internet-based cognitive behavioral intervention program designed to alleviate sexuality and intimacy problemens of women who have been treated for breast cancer.

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…

A randomized, prospective trial of 3 weeks pre-operative hormonal treatment for hormone receptor positive breast cancer: Anastrozole, Fulvestrant or Tamoxifen Exposure - Response in molecular profile (AFTER).

To investigate prospectively how the "TAMRO-profile" performs in a pre-operative treatment setting. In addition we can examine whether the profile is specific for tamoxifen or is predictive for endocrine resistance in general. Also the…

Ambulatory SNP under local anaesthesia in a subgroup of breast cancer patients - trial

Reduction of the mean number of operations under general anaesthesia per patient. Improvement of Quality of Life. Reduction of depressive symptoms and experienced anxiety.

A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer (CLEE011A 2201)

Primary objective: To estimate the difference in anti-proliferative activity of LEE011 600 mg QD and LEE011 400 mg QD in combination with letrozole 2.5 mg QD vs single agent letrozole 2.5 mg QD as measured by changes in Ki-67 levels from baseline to…

High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency

This study will investigate whether oligometastatic triple negative or BRCA1/2 related breast cancer can be treated effectively with a multimodality approach including induction chemotherapy, and whether high dose alkylating chemotherapy can improve…

Effect evaluation of a Decision Aid for Fertility Preservation in Women with Breast cancer; a Randomized Controlled Trial in the Netherlands

Aim of the hereby proposed study is to evaluate the DA for FP on its effectiveness compared to treatment as usual (TAU) regarding outcomes of decision making and decision making processes. Primary outcome is decisional coflict.

Randomized, single dose, parallel group, bioequivalence study, comparing trastuzumab (Synthon BV, the Netherlands) to Herceptin® (Hoffmann-La Roche, Switzerland) infusion in healthy male volunteers following a placebo-controlled dose escalation period

MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…

A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination with Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer who are refractory to Letrozole or Anastrozole.

To compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer that is refractory to non-steroidal aromatase…

The influence of supplementary regional infiltration anesthesia with ropivacaine on postoperative pain, nausea and vomiting in patients undergoing mamma surgery under general anesthesia

To investigate that in mamma surgery, regional infiltration with ropivacaine 0,75% added to general anaesthesia causes less postoperative pain, nausea and vomiting compared to general anaesthesia alone.

LUX-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine iv chemotherapy as treatment in patients with HER2-overexpressing, metastatic breastcancer, who failed one prior trastuzumab treatment.

The efficacy of radioguided occult lesion localisation (ROLL) versus wire guided lesion localisation (WGL) in breast conserving surgery for non palpable breast cancer: a randomised controlled trial

To evaluate the efficacy of ROLL versus WGL in breast conserving surgery for non-palpable breast cancer.

Phase III randomized trial with neoadjuvant chemotherapy (TAC) with or without zoledronic acid for patients with large resectable or locally advanced HER2-negative breast cancer.

In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…

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…

A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness, fatigue and quality of life.

This present study aims to investigate the effectiveness and cost-effectiveness of a high intensity exercise program, a low-to-moderate intensity exercise program and a waiting list control group on physical fitness (cardiorespiratory fitness and…

A Phase I/Ib, Multicentre, Study Comprising a Safety Run-In of AZD5363 when Combined with Paclitaxel in Patients with Advanced or Metastatic Breast Cancer; Followed by a Randomised Expansion of AZD5363 when Combined with Paclitaxel vs. Paclitaxel plus Placebo in Patients with ER-Positive Advanced or Metastatic Breast Cancer, Stratified by PIK3CA Mutation Status (BEECH).

The main purpose of the study is to establish an optimal and safe dose of AZD5363 when combined with paclitaxel. It will also indicate whether AZD5363, in combination with paclitaxel, has an effect on the type of breast cancer that you have. This…

A randomised Phase III study of radiation doses and fractionation schedules for ductal carcinoma in situ (DCIS) of the breast

To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy. To individualise treatment selection for women with DCIS to achieve long term disease control with minimal toxicity

Tired of being fatigued? Extending evidence-based treatment options for fatigued breast cancer survivors using the internet

Increase the evidence-based treatment options by testing the efficacy of self-guided web-based CBT for fatigued breast cancer survivors with minimal therapist support in a randomised controlled trial.