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A Phase I/II Study of Romidepsin in Combination With Abraxane in Patients With Metastatic Inflammatory Breast Cancer
This phase I/II trial studies the side effects and best dose of romidepsin when given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well they work in treating patients with metastatic inflammatory breast cancer. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving romidepsin and paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for inflammatory breast cancer.
Details
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | TERMINATED |
| Enrolment | 9 |
| Start date | 2014-04 |
| Completion | 2016-12-08 |
Conditions
- HER2-negative Breast Cancer
- Inflammatory Breast Cancer
- Male Breast Cancer
- Recurrent Breast Cancer
- Stage IV Breast Cancer
Interventions
- Romidepsin
- Abraxane
Primary outcomes
- Maximum-Tolerated Dose of Romidepsin (Phase I) — 28 days
Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0 - Progression-Free Survival (PFS) — The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Countries
United States