Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases

This study has been completed.
Sponsor:
Collaborator:
Cytogen Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00429507
First received: January 29, 2007
Last updated: October 22, 2015
Last verified: October 2015
Results First Received: October 22, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Bone Metastases
Interventions: Drug: 153 Sm-EDTMP
Behavioral: Questionnaire
Procedure: Stem Cell Transplant

  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
Recruitment period: March 7, 2007 to February 4, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Samarium 153-EDTMP + Stem Cell Transplant Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.

Participant Flow:   Overall Study
    Samarium 153-EDTMP + Stem Cell Transplant  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  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
Samarium 153-EDTMP + Stem Cell Transplant Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.

Baseline Measures
    Samarium 153-EDTMP + Stem Cell Transplant  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Median (Full Range)
  52  
  (36 to 63)  
Gender  
[units: participants]
 
Female     12  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: 7.5 Years, Study period was March 2007 to November 2014. ]


  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: Nato Ueno, MD, PhD/Professor, Breast Medical Oncology
Organization: University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429507     History of Changes
Other Study ID Numbers: 2006-0349
NCI-2010-00573 ( Registry Identifier: NCI CTRP )
Study First Received: January 29, 2007
Results First Received: October 22, 2015
Last Updated: October 22, 2015
Health Authority: United States: Food and Drug Administration