drugset / Trial / NCT01698281
Phase 2 Trial of AEZS-108 in Chemotherapy Refractory in Triple Negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer.
Timeline
- Start
- 2012-12
- Primary completion
- 2014-08
- Completion
- 2014-10
Outcome
Outcome not reported
Stopped (Enrollment): “Poor recruitment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Eribulin | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Nab-paclitaxel | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | Pegylated liposomal doxorubicin | Unknown | — | — |
| Subject | Vinorelbine | Small molecule | — | — |
| Subject | zoptarelin doxorubicin | Other / unclassified | 160 mg/m2 | Intravenous |
| Subject | zoptarelin doxorubicin | Other / unclassified | 210 mg/m2 | Intravenous |
| Subject | zoptarelin doxorubicin | Other / unclassified | 267 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 8 mg | — |