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

HER2-negative Metastatic Breast Cancer Clinical Trial

Official title: DETECT III - A Multicenter, Randomized, Phase III Study to Compare Standard Therapy Alone Versus Standard Therapy Plus Lapatinib in Patients With Initially HER2-negative Metastatic Breast Cancer and HER2-positive Circulating Tumor Cells

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-negative Metastatic Breast Cancer
• HER2-positive Circulating Tumor Cells
• Neoplastic Cells, Circulating

• NCT number: NCT01619111
• Study type: Interventional
• Source: University of Ulm
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Completion date: January 2022