Trials / Completed
CompletedNCT02035813
DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).
DETECT IV - A Prospective, Multicenter, Open-label, Phase II Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Prof. Wolfgang Janni · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer
- HER2-negative Circulating Tumor Cells
- Postmenopausal Female Patients
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ribociclib | Ribociclib/Everolimus in combination with endocrine therapy |
| DRUG | Eribulin |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2024-01-10
- Completion
- 2024-01-10
- First posted
- 2014-01-14
- Last updated
- 2024-06-04
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02035813. Inclusion in this directory is not an endorsement.