Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer
HER2-negative Breast Cancer
Inflammatory Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Romidepsin in Combination With Abraxane in Patients With Metastatic Inflammatory Breast Cancer|
- Maximum-Tolerated Dose of Romidepsin (Phase I) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0
- Progression-Free Survival (PFS) [ Time Frame: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]
- Incidence of adverse events, graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]Summary tables of grade 2, 3, and 4 toxicities, adverse events (AE), and serious adverse events (SAE) will be generated at the conclusion of the study as well as at the conclusion of phase I study and after 15 patients have been collected on at the interim evaluation time point of the phase 2 part of the study.
- Overall Response Rate (ORR) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The 95% confidence intervals should be provided.
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The 95% confidence intervals should be provided.
|Study Start Date:||April 2014|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Romidepsin and Abraxane)
Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: Abraxane
- To assess the safety of the combination of romidepsin plus Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) delivered weekly. (Phase I)
- To determine the maximum tolerated dose (MTD) of romidepsin with full dose weekly Abraxane to define a recommended phase II doses of the combination. (Phase I)
- To assess the progression-free survival (PFS) in patients with human epidermal growth factor receptor 2 (HER2) negative, newly diagnosed metastatic inflammatory breast cancer treated with the combination of romidepsin and Abraxane. (Phase II)
- To assess the safety and tolerability of the combination of romidepsin and Abraxane.
- To determine the adverse event profile of the combination of romidepsin and Abraxane.
- To assess the overall response rate (ORR) and clinical benefit rate (CBR) in patients with newly recurrent inflammatory breast cancer (IBC) treated with the combination of romidepsin and Abraxane.
OUTLINE: This is a phase I, dose-escalation study of romidepsin followed by a phase II study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01938833
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Laura Austin, MD||Thomas Jefferson University|