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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…

Breast Density as Indicator for the Use of Mammography or MRI to Screen Women with Familial Risk for Breast Cancer: a RCT.

To assess, based on a woman*s risk profile, mammographic density and age, the most cost-effective screening method, mammography or MRI, for women at high risk.

Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy
(PHM) in the elderly HER2+ metastatic breast cancer population who may
continue on T-DM1 alone following disease progression while on PH / PHM:
an open-label multicentre randomized phase II selection trial of the EORTC
Elderly Task Force and Breast Cancer Group

The main objectives are to evaluate the efficacy (as measured byprogression free survival at 6 months) of pertuzumab combined withtrastuzumab (PH) or PH plus metronomic chemotherapy (PHM) in anelderly metastatic breast cancer population, and to…

A randomized phase II trial of pertuzumab in combination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer

Primary objectivesThe primary objective of this trial is to evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inbibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line…

DIetary REstriction as an adjunct to neoadjuvant ChemoTherapy
for HER2 negative breast cancer

PrimaryDoes a peri-chemotherapeutic FMD ameliorate grade III or IV toxicity (Phase II part) and increase pathologic complete response (pCR) in patients with HER2 negative early breast cancer treated with neoadjuvant chemotherapy (Phase III part).…

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence

The purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…

Magnetic Marker Localization for breast cancer surgery: An exploratory study

The purpose of this clinical study is to investigate surgical usability, patient-reported outcomes and effectiveness of the MaMaLoc technique and compare it with WGL.

The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch multicentre cohort study l

The study aim is to decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. Therefore, we investigate whether completion axillary…

A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician*s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer;patients

Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…

Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study

To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…

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…

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 Ib/II Randomized Study of BI 836845 in Combination with Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women with Locally Advanced or Metastatic Breast Cancer

Objecive of phase I was the determination of the maximum tolerated dose (MTD) and recommended phase II dose of BI836845 in combination with exemestane and everolimus in women with HR+ / HER2- locally advanced or metastatic breast cancer.Ojective of…

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…

Molecular studies on reduced ovarian reserve and embryo competence in BRCA1/2 mutation carriers

Investigate the association between BRCA1/2-mutations, DNA damage, apoptosis and oocyte/embryo quality in immature germinal vesicle (GV) bearing oocytes, immature metaphase 1 (MI) and unfertilized mature metaphase 2 (MII) oocytes and affected early-…

Caphosol as a therapeutic option in patients with breast- or colorectal cancer at risk for chemotherapy-induced oral mucositis

To evaluate the effectiveness of a calcium phosphate mouth rinse (Caphosol) on the burden of disease of moderate and severe oral mucositis (WHO scale grade II-IV). In breast cancer patients receiving FE90C x6 (q3w), FE100C x3 (q3w) followed with…

Improved diagnosis of clinically occult breast lesions

To assess whether the use of RFIB instead of LCNB increases the probability of a definitive preoperative histological diagnosis in women with suspicious mammographic breast lesions. assess the *RFIB success rate*, defined as the proportion of…

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with
Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus
Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

The primary objective of the study is to assess the progression-free survival (PFS) of oralveliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel.The…

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 effect of a paravertebral block on postoperative pain in patients with breast cancer.

We want to investigate wether a para-vertebral block contributes to a reduced postoperative pain and morphine consumption in patients with breast cancer after a unilateral mastectomy or lumpectomy. By doing this investigation we hope to clarify,…