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neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination with Anastrozole to those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy with Abemaciclib in Combination with Anastrozole in Postmenopausal Women with Hormone Receptor Positive, HER2 Negative Breast Cancer

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…

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).

The effect of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with breast cancer *the ELDORADO study*

The main objective is: To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).Secundary objectives are:1. Other pharmacokinetic outcomes (i.e. clearance, minimum…

Phase I interaction study of Docetaxel and Tolbutamide with supplementation of Milk Thistle

Primary objective: To determine pharmacokinetic interactions between milk thistle and docetaxel and between milk thistle and tolbutamide in patients with cancer.Secundary objective: To determine the safety of the use of milk thistle in combination…

RANDOMIZED PHASE II/III STUDY OF SECOND-LINE ENDOCRINE TREATMENT FOLLOWED BY CAPECITABINE VERSUS CAPECITABINE FOLLOWED BY ENDOCRINE TREATMENT IN PATIENTS WITH METASTATIC ER POSITIVE BREAST CANCER

This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time…

The OPTIMAL study:
Optimizing Performance of afiniTor by splitting Intake Moments and decreasing Adverse events whilst maintaining outcome quaLity.

To describe and compare pharmacokinetics of everolimus in a 10 mg QD and everolimus 5mg BID schedule, evaluated PK parameters will be a.o. Cmax/Cmin ratio, AUC, Cmax, Cmin, Tmax.

Study on the pharmacokinetic interaction between diclofenac and tamoxifen in patients with breast cancer. "the DICLOTAM study"

Primary objective1. To compare the Area under the curve (AUC) of endoxifen in patients with breast cancer treated with tamoxifen with and without diclofenac.Secondary objectives1. To compare the Area under the Curve (AUC) of tamoxifen and endoxifen-…

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors
Express PD-L1

This study has been transitioned to CTIS with ID 2023-504194-21-00 check the CTIS register for the current data. Primary Objective:- To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between…

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician*s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1.

This study has been transitioned to CTIS with ID 2023-504195-14-00 check the CTIS register for the current data. •To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between sacituzumab govitecan (SG)…

Study on the possible pharmacokinetic interaction between grean tea supplements and tamoxifen in patients with breast cancer. "the TEA study"

Primary objective:1. To compare the change from baseline of the Area under the curve (AUC) of tamoxifen in patients with breast cancer treated with tamoxifen with and without green tea supplements.Secondary objectives:1. To compare the Area under…

Effect of the moderate CYP3A4-inhibitor erythromycin on the pharmacokinetics of palbociclib

The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…