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

NCT02035813 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-06-04

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Ribociclib

Ribociclib/Everolimus in combination with endocrine therapy

DRUG

Eribulin

Sponsors & Collaborators

  • Prof. Wolfgang Janni

    lead OTHER

Principal Investigators

  • Tanja Fehm, MD, PhD · University Hospital Düsseldorf -Department of Gynecology

  • Wolfgang Janni, MD, PhD · University Hospital Ulm -Department of Gynecology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2024-01-10
Completion
2024-01-10

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02035813 on ClinicalTrials.gov