drugset / Trial / NCT02035813

DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).

NCT02035813

Phase 2 Completed 116 enrolled University of Ulm
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Several studies have indicated that determining prevalence and number of circulating tumor cells (CTCs) at various time points during treatment may be an effective tool for assessing treatment efficacy in metastatic breast cancer (MBC). However, even if the prognostic value of CTCs in MBC is well understood, the role of both CTC prevalence and CTC phenotype in predicting treatment response needs further investigation. DETECT IV is a prospective, multicenter, open-label, phase II study in patients with HER2-negative metastatic breast cancer and persisting HER2-negative circulating tumor cells (CTCs). Additional research on CTC dynamics and characteristics will provide a better understanding of the prognostic and predictive value of CTCs and is one step into a more personalized therapy for MBC.

Timeline

Start
2014-01
Primary completion
2024-01-10
Completion
2024-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule
Subject Ribociclib Small molecule