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Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01091454
First received: March 18, 2010
Last updated: January 31, 2017
Last verified: January 2017
Results First Received: December 7, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Triple-negative Breast Cancer
Interventions: Drug: brostallicin
Drug: cisplatin

  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
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 (Cisplatin and Brostallicin) Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Cisplatin and Brostallicin)
STARTED   48 
COMPLETED   47 
NOT COMPLETED   1 
Ineligible                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
Treatment (Cisplatin and Brostallicin) Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Treatment (Cisplatin and Brostallicin) 
Overall Participants Analyzed 
[Units: Participants]
 47 
Age 
[Units: Years]
Median (Full Range)
 57 
 (34 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      47 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   47 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   3-month Progression-free Survival (3-mo PFS) Rate   [ Time Frame: 3 months ]

2.  Secondary:   Confirmed Response Rate   [ Time Frame: Up to 5 years ]

3.  Secondary:   Duration of Response   [ Time Frame: Up to 5 years ]

4.  Secondary:   6-month Progression-free Survival (6-mo PFS) Rate   [ Time Frame: At 6 months ]

5.  Secondary:   Time to Disease Progression   [ Time Frame: up to 5 years ]

6.  Secondary:   Survival Time   [ Time Frame: Up to 5 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: Alvaro Moreno-Aspitia MD
Organization: Mayo Clinic
phone: 507-284-1159
e-mail: morenoaspitia.alvaro@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01091454     History of Changes
Other Study ID Numbers: N0937
NCCTG-N0937
CDR0000665441 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-02016 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Study First Received: March 18, 2010
Results First Received: December 7, 2016
Last Updated: January 31, 2017