DETECT III - A Multicenter, Phase III Study to Compare Standard Therapy +/- Lapatinib in HER2-ve MBC-Patients With HER2+ve CTCs (DETECT III)
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.
|HER2-negative Metastatic Breast Cancer HER2-positive Circulating Tumor Cells||Drug: standard chemo- or endocrine therapy Drug: standard chemo- or endocrine therapy + Lapatinib||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- CTC clearance rate [ Time Frame: 8 - 12 weeks ]CTC clearance rate: Proportion of patients with at least one CTC detected in 7.5 ml of peripheral blood drawn before treatment that show no evidence of CTCs in the blood after treatment (CTC prevalence as assessed using the Cell-Search® System; Veridex LLC, Raritan, USA)
- Overall response rate [ Time Frame: 8-12 weeks ]Rate of complete (CR) and partial responses (PR) in patients with whom target lesions were defined
- Clinical benefit rate [ Time Frame: 8-12 weeks ]Rate of patients who were assessed PR or CR or who had stable disease (SD) for at least 6 months.
- Overall survival [ Time Frame: 4 weeks ]Time from randomization until death of any cause
- Dynamic of CTC [ Time Frame: 8-12 weeks ]Descriptive statistics of regular CTC counts
- Quality of life (QoL) [ Time Frame: 4 weeks ]As assessed by evaluation of the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires.
- Safety and tolerability of lapatinib [ Time Frame: 4 weeks ]Assessed by evaluation of adverse event (AE) reports.
- Intensity of pain [ Time Frame: 4 weeks ]Measured by use of numeric rating scale (NRS)
- Progression free survival (PFS) [ Time Frame: 8 - 12 weeks ]Time interval from randomization until progressive disease (PD) or death from any cause, whichever comes first
- Level of compliance to study protocol. [ Time Frame: 4 weeks ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||March 2020|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Active Comparator: standard therapy
standard chemo- or endocrine therapy
Drug: standard chemo- or endocrine therapy
standard chemo- or endocrine therapy:
Experimental: standard therapy + lapatinib
standard chemo- or endocrine therapy + lapatinib
Drug: standard chemo- or endocrine therapy + Lapatinib
+ standard chemo- or endocrine therapy:
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619111
|Contact: Susanne Albrecht, MD||+49 731 email@example.com|
|Contact: Fabienne Schochter, MD||+49731 firstname.lastname@example.org|
|University Hospital Ulm||Recruiting|
|Ulm, Baden-Württemberg, Germany, 89075|
|Principal Investigator: Wolfgang Janni, MD, PhD|
|Principal Investigator:||Tanja Fehm, MD, PhD||Heinrich-Heine University, Duesseldorf|
|Study Director:||Wolfgang Janni, MD, PhD||University Hospital Ulm|