MedTrace Logo

DETECT III - A Multicenter, Phase III Study to Compare Standard Therapy +/- Lapatinib in HER2-ve MBC-Patients With HER2+ve CTCs

NCT01619111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-06-04

No results posted yet for this study

Summary

The HER2 status in breast cancer patients may change during the course of the disease. In 30% of initially HER2-negative patients with circulating tumor cells (CTC), HER2-positive CTCs can be detected in peripheral blood samples(1). At present, it is unclear if therapy based on the HER2 status of CTC offers a clinical benefit for these patients. The DETECT III - trial compares lapatinib, as HER2-targeted therapy in combination with standard therapy versus standard therapy alone in those patients, with initially HER2-negative metastatic breast cancer and HER2-positive circulating tumor cells.

As one of the first interventional trials based on the assessment of CTC phenotypes, the DETECT III - trial aims to evaluate the efficacy of HER2-targeted therapy in patients with MBC and HER2-positive CTCs as well as the significance of CTC as an early predictive marker for treatment response.

Conditions

  • HER2-negative Metastatic Breast Cancer
  • HER2-positive Circulating Tumor Cells

Interventions

DRUG

standard chemo- or endocrine therapy

standard chemo- or endocrine therapy: * Monochemotherapy (containing one of the following): docetaxel, paclitaxel, vinorelbine, capecitabine, NPLD (non-pegylated liposomal doxorubicin) * Endocrine therapy: aromatase inhibitors (anastrozole, letrozole, exemestane)

DRUG

standard chemo- or endocrine therapy + Lapatinib

Lapatinib \+ standard chemo- or endocrine therapy: * Monochemotherapy (containing one of the following): docetaxel, paclitaxel, vinorelbine, capecitabine, NPLD (non-pegylated liposomal doxorubicin) * Endocrine therapy: aromatase inhibitors (anastrozole, letrozole, exemestane)

Sponsors & Collaborators

  • Prof. Wolfgang Janni

    lead OTHER

Principal Investigators

  • Tanja Fehm, MD, PhD · Heinrich-Heine University, Duesseldorf

  • Wolfgang Janni, MD, PhD · University Hospital Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT01619111 on ClinicalTrials.gov