DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).
- Sponsor
- Prof. Wolfgang Janni
- Study ID
- NCT02035813
- Phase
- PHASE2
- Status
- Completed
Conditions
- HER2-negative Circulating Tumor Cells
- HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer
- Postmenopausal Female Patients
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ribociclib — DRUGRibociclib/Everolimus in combination with endocrine therapy
- Eribulin — DRUG
Study Details
Several studies have indicated that determining prevalence and number of circulating tumor cells (CTCs) at various time points during treatment may be an effective tool for assessing treatment efficacy in metastatic breast cancer (MBC). However, even if the prognostic value of CTCs in MBC is well understood, the role of both CTC prevalence and CTC phenotype in predicting treatment response needs further investigation. DETECT IV is a prospective, multicenter, open-label, phase II study in patients with HER2-negative metastatic breast cancer and persisting HER2-negative circulating tumor cells (CTCs). Additional research on CTC dynamics and characteristics will provide a better understanding of the prognostic and predictive value of CTCs and is one step into a more personalized therapy for MBC.
Key Dates
- Start date
- Jan 31, 2014
- Status verified
- Jun 2024
- Primary completion
- Jan 10, 2024
- Completion
- Jan 10, 2024
Study Design
- Enrollment
- 116 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ribociclib in combination with standard endocrine therapyPostmenopausal female patients with hormone-receptor positive, HER2-negative metastatic breast cancer with HER2-negative circulating tumor cells (CTCs) and indication for standard endocrine therapy.
- Experimental: EriubulinPatients with hormone-receptor positive, HER2-negative metastatic breast cancer and indication to chemother-apy or patients with triple-negative metastatic breast cancer, both with HER2-negative circulating tumor cells (CTCs).
Primary Outcome Measure
Progression free survival (PFS) [ Time Frame: 8-12 weeks ]