44 results
Primary: To estimate the MTD or RDE and preferred dosing schedule of LJM716 when administered in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer or gastric cancer.Secondary: Safety and tolerability, PK, PD…
The main goal of neoadjuvant therapy should be a pathological complete response (pCR), because pCR more accurately predicts improved patient outcome and prolonged survival. In the present study, pathological response will be evaluated by The Miller…
Primary Objective:The primary objective is to compare the radiographic progression-free survival (rPFS) ofapalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone(AAP) and AAP in subjects with chemotherapy-naïve mCRPC…
To demonstrate that the Cerebral Embolic Protection Device (TriGUARD*3) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) leads to less brain injury as assessed by transcranial Doppler measurements.
The primary objective of this study is to show equivalence of the total pathological complete response rate (tpCR) in patients treated withHD201 plus chemotherapy to that in patients treated with Herceptin® plus chemotherapy. tpCR will be assessed…
Primary Objective:The primary objective of this study is to evaluate the efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared to trastuzumab…
Primary ObjectivesPart A: RO6874281 Dose Escalation as a Single AgentThe primary objectives for this study are as follows:* To describe the safety and tolerability profile of RO6874281 as a single agent* To determine the maximum tolerated dose (MTD…
The primary objective is to determine if metastatic breast cancer patients with HER2-negative primary tumors but with at least one HER2-positive CTC benefit from trastuzumab-containing chemotherapy. Secondary objectives are to determine the impact…
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…
Primary ObjectiveTo determine the incidence and grading of infusion related/hypersensitivity reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) criteria for: infusion related reaction during…
Primary ObjectiveTo evaluate the antitumor activity of tucatinib given in combination with trastuzumab in subjects with previously treated, locally-advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) overexpressing/…
• To evaluate the safety and tolerability of Runimotamab when administered as a single agent (Phase Ia) and in combination with trastuzumab (Phase Ib)• To determine the maximum tolerated dose (MTD), to identify the recommended phase II dose (RP2D),…
Primary Objectives:- To determine the BE of a RS FDC tablet formulation of niraparib and Abiraterone Acetate with respect to niraparib and Abiraterone Acetate co-administered as single agents at steady state under modified fasted conditions in…
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…
In the so-called adenocarcinoma of the esophagus, the HER2 receptor can be detected in about 15% of the tumors. Based on the phase II TRAP study performed in the Netherlands, we aim to demonstrate in this study that by adding trastuzumab and…
Primary objective To investigate the safety and tolerability of CCS1477 as monotherapy and in combination.
To evaluate safety and feasibility of neoadjuvant chemotherapy-free regimen with trastuzumab, pertuzumab and tucatinib in stage II-III HER2-positive breast cancer.
To determine the activity (as measured by objective response rate by RECIST1.1) of monalizumab and trastuzumab in patients with metastatic HER2-positive breast cancer.
To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
Primary objective:- To compare the efficacy of zanidatamab in combination with chemotherapy or in combination with chemotherapy and tislelizumab to the efficacy of trastuzumab in combination with chemotherapy in subjects with unresectable locally…