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Trial record 16 of 130 for:    inflammatory breast cancer AND Cancer Center

Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01938833
Recruitment Status : Terminated (Closed by Sponsor)
First Posted : September 10, 2013
Results First Posted : September 29, 2017
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HER2-negative Breast Cancer
Inflammatory Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: Romidepsin
Drug: Abraxane

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Romidepsin

Abraxane


Participant Flow:   Overall Study
    Treatment (Romidepsin and Abraxane)
STARTED   9 
COMPLETED   9 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Romidepsin

Abraxane


Baseline Measures
   Treatment (Romidepsin and Abraxane) 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.6  (9.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      9 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      9 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   9 


  Outcome Measures

1.  Primary:   Maximum-Tolerated Dose of Romidepsin (Phase I)   [ Time Frame: 28 days ]

2.  Primary:   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 ]

3.  Secondary:   Incidence of Adverse Events, Graded According to NCI CTCAE Version 4.0   [ Time Frame: Up to 30 days ]

4.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Up to 5 years ]

5.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Maysa Abu-Khalaf
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
phone: 215 503-4685
e-mail: maysa.abu-khalaf@jefferson.edu


Publications:
Desai N, Trieu V, Yao R, et al. Increased transport of nanoparticle albumin-bound paclitaxel (ABI-007) by endothelial gp60-mediated caveolar transcytosis: a pathway inhibited by Taxol. Eur J Cancer Suppl. 2004;2:182.


Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT01938833     History of Changes
Other Study ID Numbers: 13C.387
2013-035 ( Other Identifier: CCRRC )
First Submitted: September 5, 2013
First Posted: September 10, 2013
Results First Submitted: September 5, 2017
Results First Posted: September 29, 2017
Last Update Posted: December 28, 2017