370 results
The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…
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…
1. To validate accelerometer cut-points to asses physical activity and sedentary behavior of breast cancer survivors. 2. To investigate the validity of accelerometers, inclinometers, heart rate and oxygen consumption to assess time spent in…
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.
To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
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…
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…
To establish biomarkers in nipple aspirate fluid, follow them in time and link them to breast cancer development at its earliest stage in women at high risk for breast cancer. Threshold values of biomarkers will be determined that point to a…
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).…
To define the maximal tolerated dose (MTD) of olaparib in combination with radiotherapy of the breast and regional lymph nodes in patients with breast cancer without the use of skin bolus (arm A) or with the use of skin bolus (arm B).
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, wire localization).The…
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 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…
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…
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…
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…
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…
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.…
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…
The primary objective of this clinical study is to identify whether activating mutations in ESR1 detected in circulating tumor DNA (ctDNA) in peripheral blood are associated with resistance to endocrine therapy in patients with ER-positive, human…