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A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases treated with hormonal treatment background therapy

The objective of this study is to assess the efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative), hormone receptor positive breast cancer with bone metastases treated with…

Couple therapy for cancer survivors : A prospective, randomized controlled study.

The primary objective of the study is to gain insight in the short term and long term effects of the EFCT-ODA therapy on 1) dyadic coping abilities in the relationship and 2) relational satisfaction. Moreover, the process aspects of the ODA will be…

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.…

A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with exemestane and everolimus versus placebo in combination with exemestane and everolimus when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases.

The objective of this study is to assess efficacy and safety of radium 223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer…

Systemic therapy with or without Up front surgery of the primary tumor in Breast cancer patients with distant Metastases at Initial presenTation (SUBMIT, BOOG 2010-05)

Up front breast surgery in patients with primary distant metastatic breast cancer, will result in an improvement of the 2-year survival compared to the survival achieved with systemic therapy and delayed local treatment or systemic therapy alone.The…

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.

Informing relatives about their cancer risk and preventive measures. A trial to assess the effectiveness of additional counseling.

The aim of this study is to evaluate an intervention aimed at improving family disclosure of inherited cancer risks by 1) supporting counselees in what they experience as a necessary, but at times difficult, task and, consequently 2) provide more at…

The influence of peroperative dobutamine infusion on the blood flow of the DIEP-flap

Primary Objective: To investigate in a prospective randomized controlled trial whether intravenous infusion of low doses dobutamine solely peroperative or for 18 more hours postoperative in women undergoing a breast reconstruction by means of a DIEP…

A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy of post-menopausal women with estrogen
receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancer

PrimaryDemonstration of superior efficacy (as measured by PFS time) of L-BLP25 in combination with hormonal treatment (HT) over placebo plus HT, when used for first-line therapy of hormone receptor-positive (ER+ and/or PgR+), inoperable locally…

A RANDOMIZED PHASE II STUDY OF CONCOMITANT TRASTUZUMAB, BEVACIZUMAB WITH PACLITAXEL VERSUS TRASTUZUMAB AND BEVACIZUMAB FOLLOWED BY THE COMBINATION OF TRASTUZUMAB, BEVACIZUMAB AND PACLITAXEL AT PROGRESSION AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER WITH HER2-NEU OVEREXPRESSION

Primary objective: To establish whether concomitant therapy of trastuzumab, bevacizumab with paclitaxel (regimen A) and/or trastuzumab and bevacizumab followed by the combination of trastuzumab, bevacizumab, and paclitaxel at progression (regimen B…

A phase 1 randomized, double-blind, placebo-controlled, maximum tolerated dose escalation, safety, tolerability and pharmacokinetic adaptive study of RAD1901 administered to healthy postmenopausal women

The purpose of the study is to investigate to what extent RAD1901 is tolerated.It will also be investigated how quickly and to what extent RAD1901 is absorbed and eliminated from the body.In addition, in Group 6 it will be investigated to what…

A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

This study has been transitioned to CTIS with ID 2024-511096-15-00 check the CTIS register for the current data. To assess the safety and tolerability of adjuvant treatment with olaparib

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC).

The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…

*An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer*

Primary:The primary objective of this study is to demonstrate that the overall progression-free survival (PFS) of 8 cycles of intermittent (2 times 4 cycles) chemotherapy (paclitaxel) is not inferior in efficacy, compared to 8 continuous cycles of…

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

Determine the efficacy and safety (using objective response rate) of tremelimumab in patients with advanced solid tumors (UBC, PDAC, TNBC).