OncRef

Clinical Trial: NCT02035813

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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Prof. Wolfgang Janni
Information Provided By:University of Ulm
Last Update Posted:2024-06-04

Study Overview

Brief 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.

Official Title

DETECT IV - A Prospective, Multicenter, Open-label, Phase II Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).

Conditions

HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer, HER2-negative Circulating Tumor Cells, Postmenopausal Female Patients

Intervention / Treatment

  • Drug: Ribociclib
  • Drug: Eribulin

Other Study ID Numbers

  • D-IV
  • 2013-001269-18

Start Date (Actual)

2014-01

Primary Completion Date (Actual)

2024-01-10

Study Completion Date (Actual)

2024-01-10

Enrollment (Actual)

116

Study Type

Interventional

Phase

Phase 2