Search for a trial

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 multicenter randomized phase III study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA)

To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).

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).…

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…

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…

An open label, randomized phase III trial comparing 2.5 year duration of letrozole (Femara) treatment with 5 year duration in patients previously treated for endocrine sensitive early breast cancer

PrimaryTo investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 yearsSecondaryTo…

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 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.

An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI

To assess the effectivity and safety of 1.0 molar gadobutrol (Gadovist®) for breast MRI

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…

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…

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

Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery.

This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and Patent Blue) in detecting…

Cognitive behavioral therapy (CBT) and physical exercise for climacteric symptoms in breast cancer patients experiencing treatment-induced menopause: a multicenter randomized trial.

The proposed study will evaluate the efficacy of a supportive intervention program in alleviating menopausal symptoms, improving sexual functioning and enhancing the quality of life of younger women (< 50 years) with breast cancer who have…

Cognitive behavioral therapy (CBT) and physical exercise for climacteric symptoms in breast cancer patients experiencing treatment-induced menopause.

The proposed study will evaluate the efficacy of a supportive intervention program in alleviating menopausal symptoms, improving sexual functioning and enhancing the quality of life of younger women (< 50 years) with breast cancer who have…

Chemotherapy Adjuvant Study for women at advanced Age (CASA); Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx®, Doxil®) for Women (age 66 years or older) with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a *Standard Chemotherapy Regimen*

The overall aim of the CASA trial is to investigate the role of PLD as adjuvantchemotherapy for older postmenopausal women for whom chemotherapy is indicated, but standard regimens, derived from trials in younger women, are assumed to be too toxic…