NCT01619111

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Prof. Wolfgang Janni · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2012-02-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2012-06-14
• Last updated: 2024-06-04

Locations

1 site across 1 country: Germany