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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• standard chemo- or endocrine therapy — DRUG
  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)
• standard chemo- or endocrine therapy + Lapatinib — DRUG
  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)

Study Details

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.

Key Dates

Start date

Feb 29, 2012

Status verified

Jun 2024

Primary completion

Jan 31, 2022

Completion

Jan 31, 2022

Study Design

Enrollment

105 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: standard therapy
  standard chemo- or endocrine therapy
• Experimental: standard therapy + lapatinib
  standard chemo- or endocrine therapy + lapatinib

Primary Outcome Measure

CTC clearance rate [ Time Frame: 8 - 12 weeks ]