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Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer

This study has been terminated.
(Competing studies)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00176488
First received: September 12, 2005
Last updated: September 18, 2013
Last verified: September 2013
Results First Received: September 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: epirubicin
Drug: vinorelbine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) from June 2003 through May 2009.

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
Sequential Epirubicin/Vinorelbine

For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.

epirubicin : Epirubicin (100 mg/m2) will be given on Day 1

vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.


Participant Flow:   Overall Study
    Sequential Epirubicin/Vinorelbine  
STARTED     31  
COMPLETED     30  
NOT COMPLETED     1  
Initiated Cycle 1 Day 1 only                 1  



  Baseline Characteristics
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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
Sequential Epirubicin/Vinorelbine

For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.

epirubicin : Epirubicin (100 mg/m2) will be given on Day 1

vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.


Baseline Measures
    Sequential Epirubicin/Vinorelbine  
Number of Participants  
[units: participants]
  31  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  50.0  ± 10.6  
Gender  
[units: participants]
 
Female     31  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer.   [ Time Frame: 10 years ]

2.  Secondary:   Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells.   [ Time Frame: 10 years ]

3.  Secondary:   Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4).   [ Time Frame: 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Deborah Toppmeyer, MD
Organization: Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: toppmede@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu


No publications provided


Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00176488     History of Changes
Other Study ID Numbers: CDR0000539565, P30CA072720, CINJ 040302
Study First Received: September 12, 2005
Results First Received: September 18, 2013
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board